Congress Passes Bill with Billions for Cancer Research

But some consumer groups say new standards for drug approvals could put patients at risk

Consumer Reports / Teresa Carr / December 7, 2016

Congress has passed the most expensive and far-reaching health reform bill since the Affordable Care Act in 2010.

The 21st Century Cures Act, which garnered widespread, bipartisan support in both the House and Senate, is expected to be signed into law by President Obama soon.

The bill signifies an investment of billions of dollars over the next decade to fight cancer, prevent and treat brain disorders, and harness enormous amounts of data to develop individualized treatments based on person’s environment, genes, and lifestyle.

But the bill also lowers the bar for the kind of scientific evidence companies must provide to gain the Food and Drug Administration’s (FDA) approval for their products. It would mean, for instance, that in some circumstances the FDA could rely in part on individual patient experiences with a drug or device, instead of evidence from large-scale, randomized controlled clinical trials.

Rep. Fred Upton, the Republican from Michigan who chairs the House Energy and Commerce Committee and co-sponsored the bill, says the Cures Act "expedites the approval of drugs and devices and includes literally billions of dollars in additional spending for health research so that we can find a cure and the answers to what patients are demanding today.”

Consumer groups, including Consumers Union, the policy and moblization arm of Consumer Reports, have deep concerns that this effort to speed medical innovation comes with a potentially harmful tradeoff for consumers.

“The unfortunate consequence of 21st Century Cures is that less thoroughly tested medications and medical devices will reach the market,” says Lisa McGiffert, director of Consumer Reports’ Safe Patient Project. “And that means that consumers will have less assurance that a new treatment will help and not harm them.”

More Research Dollars

The bill directs $4.8 billion over the next decade to research, in part, to fight cancer.

“Considering that one in two men and one in three women will be diagnosed with cancer in their lifetime, cancer research funding is an investment in yours, mine, and everyone’s health,” says David Pugach, vice president of federal relations at the American Cancer Society Cancer Action Network, the advocacy arm of the ACS.

Pugach says 21st Century Cures represents a “historic opportunity” to accelerate cancer research. “This includes devoting more resources to improve and use new treatments like immunotherapy,” he says, “where the body’s own defenses are used against cancer—as well as creating ways for researchers to more easily share data so they can see patterns across studies more quickly.”

The bill also allocates funds to treat brain disorders, combat opioid abuse, improve suicide prevention programs, and provide mental health care to children. It establishes a task force for research on women who are pregnant or breastfeeding because these women are typically excluded from medical studies.

Faster Drug Approvals, But Lower Standards

The Cures Act loosens requirements for how drugs are studied and approved that have been in place since 1962.

Here's how it usually works: A company submits evidence from studies done under controlled conditions, comparing patients who received the treatment with those who didn't. The studies typically have to show that people who were given the new drug lived longer or felt better than those who didn't get it.

This kind of research can be expensive and time-consuming for drug companies to collect, says Diana Zuckerman, Ph.D., president of the National Center for Health Research, a nonprofit think tank focused on health research. Cancer drugs, for example, can take several years to show that a drug improves survival.

The Cures Act calls on the FDA to approve some drugs more quickly, based on less thorough testing. The problem with this, says Zuckerman, is that “getting drugs to market faster doesn’t help consumers at all if they turn out not to work or causes them harm.”

What Consumers Should Know

Once the Cures Act takes effect, consumers must be especially careful when considering a new medication or medical device, says Orly Avitzur, M.D., Consumer Reports’ medical director.

"When you have a choice, you may want to consider treatments with a proven track record, as you'll have more assurance that they work and are safe," Avitzur says. "Always make sure someone has taken the time to thoroughly explain all the options to you, and the possible risks and benefits of each."

Editor's Note: These materials were made possible by a grant from the state Attorney General Consumer and Prescriber Education Grant Program, which is funded by a multistate settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin (gabapentin).

Supplements Can Make You Sick

Dietary supplements are not regulated the same way as medications. This lack of oversight puts consumers' health at risk.

Consumer Reports / Jeneen Interlandi / July 27, 2016 / Additional reporting by Laurie Tarkan and Rachel Rabkin Peachman

Calvin Jimmy Lee-White was tiny. He was born on Oct. 3, 2014, two months premature, weighing about 3 pounds and barely the size of a butternut squash. There are standards of care for treating infants that fragile, and as an attorney for the baby’s family later acknowledged, doctors at Yale-New Haven Hospital in Connecticut followed them. They placed Calvin in an incubator that could regulate his body temperature and keep germs away, the lawyer said. And they administered surfactant drugs, which help promote crucial lung development in premature infants. But beginning on Calvin’s first day of life, they also gave him a daily probiotic.

Probiotics are powders, liquids, or pills made up of live bacteria thought to help maintain the body’s natural balance of gut microorganisms. Some neonatal intensive care units (NICUs) have been giving them to preemies in recent years based on evidence that they can help ward off deadly intestinal disease.

Some doctors are concerned about that trend. Because probiotics can be classified as dietary supplements, they don’t have to be held to the same regulatory standards as prescription or even over-the-counter drugs. Manufacturers don’t have to secure Food and Drug Administration approval to sell their products, and their facilities aren’t policed the same way as pharmaceutical companies.

But the NICU at Yale-New Haven chose what looked to be a safe product. It was made by a large, seemingly reputable company, marketed specifically for infants and children, and available at drugstores across the country.

Calvin struggled anyway. His abdomen developed bulges, and surgery revealed that his intestines were overrun by a rare fungus. The infection spread quickly from his gut to his blood vessels, where it caused multiple blockages, and then into his aorta, where it caused a clot.

On Oct. 11, at just 8 days old, baby Calvin died. Government officials then launched a mournful investigation. Where did the fungus come from? And how did it get into this premature baby’s tiny body?

Unproven Treatments

The answer is that the probiotic was contaminated. The FDA tested unopened containers from the same batch of probiotic given to Calvin and discovered the same fungus that had infected his intestines. Certain lots of the product—ABC Dophilus Powder, made by the supplement manufacturer Solgar—were recalled from pharmacies and drugstores across the U.S.

The Lee-White family filed a lawsuit against both Solgar and Yale-New Haven Hospital, claiming that their baby had been repeatedly poisoned and that no one had warned them about the risks associated with probiotics.

“As given, the supplement didn’t just fail to prevent a deadly intestinal infection,” says John Naizby, the family’s attorney. “The supplement actually caused a deadly intestinal infection.” Solgar told Consumer Reports via email that it conducted a thorough investigation in cooperation with the FDA and the Centers for Disease Control and Prevention (CDC) and found no contaminants at any point in its own supply chain. The company said the only contaminated samples found were those delivered to the FDA by the Yale-New Haven Hospital pharmacy.

The hospital declined to comment for this article. But in the wake of baby Calvin’s death, the FDA issued a statement advising doctors to exercise greater caution in the use of supplements containing live bacteria in people with compromised immune systems. Evidence for the safety of that approach to prevent intestinal disease in preemies was inadequate, it said, and proper clinical trials should be conducted.

The problem stretches well beyond one tainted probiotic. Dietary supplements—vitamins, minerals, herbs, botanicals, and a growing list of other “natural” substances—have migrated from the vitamin aisle into the mainstream medical establishment. Hospitals are not only including supplements in their formularies (their lists of approved medication), they’re also opening their own specialty supplement shops on-site and online. Some doctors are doing the same. According to a Gallup survey of 200 physicians, 94 percent now recommend vitamins or minerals to some of their patients; 45 percent have recommended herbal supplements as well. And 7 percent are not only recommending supplements but actually selling them in their offices.

Consumers are buying those products in droves. According to the Nutrition Business Journal, supplement sales have increased by 81 percent in the past decade. The uptick is easy to understand: Supplements are easier to get than prescription drugs, and they carry the aura of being more natural and thus safer. Their labels often promise to address health issues for which there are few easy solutions. Want a smaller waistline? There’s garcinia cambogia for that. Bigger muscles? Try creatine. Better sex? Yohimbe. How about giving your brain a boost? Omega-3 fatty acids. Or your energy level? Ginseng.

It’s tough to say what portion of those products pose a risk to consumers. A 2013 report from the Government Accountability Office (GAO) found that from 2008 through 2011, the FDA received 6,307 reports of health problems from dietary supplements, including 92 deaths, hundreds of life-threatening conditions, and more than 1,000 serious injuries or illnesses. The GAO suggests that due to underreporting, the real number of incidents may be far greater.

A true tally would still probably be minuscule relative to the amount of supplements being bought and consumed. But there’s no reliable way to tell whether any given supplement is safe. And the fact remains that dietary supplements—which your doctor may recommend and may sit right alongside trusted over-the-counter medications or just across from the prescription drug counter—aren’t being regulated the same way as drugs.

“Not only are the advertised ingredients of some supplements potentially dangerous,” says Pieter Cohen, M.D., an assistant professor of medicine at Harvard Medical School who has studied supplements extensively and written many papers on the issue, “but because of the way they’re regulated, you often have no idea what you’re actually ingesting.”

Consumers Are in the Dark

Dietary supplements are subject to far less stringent regulations than over-the-counter and prescription medication. The FDA classifies them differently from drugs. So the companies that make and sell them aren’t required to prove that they’re safe for their intended use before selling them, or that they work as advertised, or even that their packages contain what the labels say they do.

And because of those lax policies, supplements that make their way into retail stores, doctors’ offices, and hospitals can pose a number of potential problems. They can be ineffective, contaminated with microbes or heavy metals, dangerously mislabeled, or intentionally spiked with illegal or prescription drugs. They can also cause harmful side effects by themselves and interact with prescription medication in ways that make those drugs less effective.

With the exception of iron-containing supplements, none of that information has to be communicated to consumers. Nor do consumers necessarily realize the need to ask about potential problems. According to a 2015 nationally representative Consumer Reports survey, almost half of American adults think that supplement makers test their products for efficacy, and more than half believe that manufacturers prove their products are safe before selling them.

“You see these products in drugstores or in doctors’ offices, and you assume they’re as tried and true as any other medication being sold at those places,” says Paul Offit, M.D., an infectious disease specialist at the Children’s Hospital of Philadelphia, who has written a book about the supplement industry. “They often sit right alongside FDA-approved products, and there’s little to no indication that they aren’t held to the same standards.”

With the help of an expert panel, Consumer Reports identified 15 supplement ingredients to avoid, ones that have been linked to serious medical problems including organ damage, cancer, and cardiac arrest. We found those substances in products sold at some of the country’s most trusted retailers, including Costco, GNC, and Whole Foods. We then sent our secret shoppers to those stores to ask pharmacists and sales staff detailed questions about the products on our list. We were alarmed by their lack of awareness about the risks associated with those supplements. Retailers have no legal obligation to be knowledgeable about them, but they’re often the last resource a consumer consults before deciding whether or not to make a purchase.

Continue reading the article at: http://www.consumerreports.org/vitamins-supplements/supplements-can-make-you-sick/?

Do prescription drug ads help or hurt consumers seeking relief?

To the American Medical Association, the Zoloft egg is one example of a bigger problem they say is having a negative impact on American health care. Calling for a ban of direct-to-consumer drug advertising in November, the AMA accused the ads of driving the demand for often unnecessary, expensive medication.Do prescription drug ads help or hurt consumers seeking relief?




By Chandra Johnson
Deseret News Service


Posted Apr. 20, 2016 at 12:15 PM 



Conversationally, doctors refer to it as the Zoloft "sad egg," the small, weirdly cute animated egg cowering under a rain cloud in its cartoonish struggle to regulate its sadness in one of the most iconic prescription drug ads of the early 2000s.

For pharmaceutical companies, doctors and millions of American prescription patients, it was the face that launched a thousand ads — the beginning of a $4.8 billion advertising business that has since expanded to about 80 direct-to-consumer (DTC) prescription ads an hour, according to Nielsen.

To the American Medical Association, the Zoloft egg is one example of a bigger problem they say is having a negative impact on American health care. Calling for a ban of direct-to-consumer drug advertising in November, the AMA accused the ads of driving the demand for often unnecessary, expensive medication.

"Direct-to-consumer advertising also inflates demand for new and more expensive drugs, even when these drugs may not be appropriate," AMA board chairwoman-elect Patrice A. Harris said in the AMA's announcement.

But to Pharmaceutical Research and Manufacturers of America (PhRMA), the ads serve a valuable public service in raising awareness about undertreated conditions and new treatment options.

"Providing FDA-regulated, scientifically accurate information to patients so that they are better informed about their health care and treatment options is the goal of direct-to-consumer advertising about prescription medicines," PhRMA senior communications director Holly Campbell said in an email. "DTC advertising encourages patients to visit their health care providers' offices for important conversations about health that might otherwise not take place."

While the call for a ban alone is unlikely to inspire a change to ad guidelines, it could inspire legislation to further restrict what pharmaceutical ads can and cannot include (the Food and Drug Administration declined to comment on ad regulation because of the potential for such legislation). Some doctors don't think that would be a bad thing.

"DTC ads are effective in that they increase patient/doctor conversations and prescriptions and, probably, the number of patients in genuine need of prescription therapy to get medications," said Dr. Richard Kravitz, University of California Davis professor of internal medicine. "But it also increases the number of unnecessary and harmful prescriptions for patients."

Others question what an ad ban would mean for Americans who could theoretically go their entire lives with a condition that's easily treated because they simply aren't aware of treatment options.

"It's really difficult to make a statement about all drug ads because you have the coexistence of under-treatment with some conditions, where advertising could help and overtreatment that can hurt," University of Pittsburgh public health researcher Julie Donohue said. "It's difficult for regulators to set up rules of the game that will address the lack of awareness without exacerbating the overuse problem."

Fluoroquinolones Are Too Risky for Common Infections

An FDA panel says popular antibiotics such as Cipro are overprescribed and should have stronger warnings about dangerous side effects

By Teresa Carr / Consumer Reports / Last updated: March 07, 2016

Last November, Rachel Brummert, 45, of Charlotte, North Carolina, stood before a panel of experts and described the ever-worsening series of health problems, including 10 ruptured tendons and progressive nerve damage, she’s suffered as side effects of taking the antibiotic Levaquin, a type of fluoroquinolone, for a suspected sinus infection in 2006.

The Food and Drug Administration convened the panel to consider whether the official drug labels for fluoroquinolones, a group of antibiotics that includes drugs such as Cipro and Levaquin, should be changed to more clearly spell out their risks and discourage overuse. Brummert, the executive director of the Quinolone Vigilance Foundation, was one of more than 30 people who spoke during the open public hearing portion of the meeting about how the drugs had an impact on their lives.

“I am living proof that the risks in using a fluorquinolone to treat a routine infection far outweighs the benefits,” Brummert says.

After reviewing the evidence, the 21-member FDA panel agreed. They voted overwhelmingly that, in most cases, the benefit of fluoroquinolones to treat three common illnesses—bacterial sinus infections, urinary tract infections, and some forms of bronchitis in people with chronic lung disease—was outweighed by the risk of rare, but serious side effects, including irregular heartbeats, depression, nerve damage, ruptured tendons, and seizures.

Currently, those three illnesses account for nearly one-third of all fluoroquinolones prescribed outside of hospitals in the U.S. according to data presented by Janssen Pharmaceuticals, makers of Levaquin, at the FDA meeting.

While the fluroquinolones are essential for treating serious infections such as anthrax, the FDA panel members noted that they are overprescribed for common infections where other treatments would work just as well with less risk. They called on the FDA to strengthen labeled warnings and clarify when the drugs—should—and should not—be used.

Rampant Overprescribing

Over the last 30 years, the FDA has approved five fluroquinolone antibiotics to treat one or more of three illnesses considered by the panel: ciprofloxacin (Cipro), levofloxacin (Levaquin), moxifloxacin (Avelox), ofloxacin (Floxin), and gemifloxacin (Factive). All are also available as generics.

Much of the evidence on the risks of the drugs emerged after the drugs were on the market and used by millions of patients. While medical organizations such as the Infectious Diseases Society of America have updated their guidelines to advise against prescribing fluoroquinolones for milder garden-variety infections—including most cases of bronchitis, sinus infections, and urinary tract infections—many doctors haven’t gotten the message. That's likely because these powerful antibiotics work against a wide variety of bacteria, says Lindsey R. Baden, M.D., an infectious disease physician at Brigham and Women’s Hospital in Boston, Massachusetts, an associate professor at Harvard Medical School, and a member of the FDA panel. That can lead to overprescribing.

“Fluoroquinolones play an important role in treating serious infections such as those caused by bacteria that are resistant to other types of antibiotics,” says Baden. But in the case of less severe illnesses such as a mild bacterial sinus infection or uncomplicated bladder infection, the drugs “should typically be reserved for second-line or even third-line treatment after other antibiotics have failed,” says Baden.

When to Say 'No' to Cipro and Similar Drugs

Below we’ve listed three types of infections where fluoroquinolones are often not the best first choice for treatment along with our medical advisers’ advice about what to do instead.

• Sinus infections. “The vast majority of sinus infections are caused by a virus, not a bacteria and antibiotics don’t work against viruses,” says Baden. Even if bacteria are responsible, the infection will typically clear up on it’s own in a week or so. An antibiotic such as amoxicillin may be warranted if your symptoms last longer than a week, start to improve and then worsen, or are very severe—accompanied by a fever of 101.5 or higher, for example, or extreme pain and tenderness over your sinuses. For more information see Choosing Wisely recommendations from the American Academy of Allergy, Asthma, and Immunology. 
• Urinary tract infections (UTIs). If you have symptoms of a urinary tract infection such as having to urinate frequently, pain or burning when you go, cloudy or bloody urine, and a fever, you may need an antibiotic to treat the infection. Several types of antibiotics are effective against uncomplicated bladder infections; fluoroquinolones are typically only necessary if the infection is resistant to other antibiotics or has spread to the kidneys. Note that people aged 65 and older often have bacteria in their urine, but do not need to be tested or treated for a UTI unless they have symptoms. For more information see Choosing Wisely recommendations from the American Geriatric Society. 
• Bronchitis. As with sinus infections, most cases of bronchitis, or chest colds, are caused by a virus and are not helped by taking an antibiotic. (Read our advice on what to do ease symptoms while your body fights the infection.) One exception: patients with chronic obstructive pulmonary disease (COPD), a condition that causes difficulty breathing, may benefit from antibiotics if they develop symptoms severe enough to require hospitalization. In that case, the best choice of drug depends on the several factors, including which bacteria are prevalent in your area. For more information on using antibiotics to treat respiratory illness in children see Choosing Wisely recommendations from the American Academy of Pediatrics.

All Antibiotics Have Risk

Brummert says she hopes that the FDA will act on the advisory panel’s recommendations. “Curbing unnecessary prescribing of fluoroquinolones could save thousands of Americans from needless suffering,” she says.

Baden points out that all antibiotics—not just fluoroquinolones—should be used more thoughtfully.

“Really, I think the labels for all antibiotics should be strengthened to remind doctors and patients that when the drug is unwarranted, prescribing it has no benefit and exposes patients to needless risk, however small that risk may be,” says Baden. “Antibiotics are overused; as a community we need to be having these conversations about better prescribing based on the balance of benefits to harms.”

Editor's Note: This article and related materials are made possible by a grant from the state Attorney General Consumer and Prescriber Education Grant Program, which is funded by the multistate settlement of consumer-fraud claims regarding the marketing of the prescription drug Neurontin (gabapentin).

Why Where You Store Prescription Painkillers Is So Important

Consumer Reports / Lisa Gill/ December 2015

Deaths due to these powerful drugs are on the rise, 

but our poll finds most people don’t secure them

Americans have a lot of painkillers sitting around in their homes, and some of these unused drugs can pose dangers to children and others.

In fact, of those who take any kind of prescription medication, more than 80 percent of people in a recent Consumer Reports poll said that they don’t lock up their narcotic painkillers, such as Oxycontin, Percocet, and Vicodin—and nearly three-quarters said they had children living at home. That translates to more than 16 million households across the U.S. where powerful opioid painkillers sit unsecured in medicine cabinets, closets, and kitchen drawers. 

The Consumer Reports National Research Center conducted the telephone poll of a nationally representative sample of more than 2,000 U.S. adults in June 2015.

The results are concerning because too many of those potentially deadly drugs wind up in the wrong hands. Pain relievers are by far the most commonly abused prescription drugs, with more than half of people who abuse them reporting that they got the drugs for free from family and friends, according to the National Institute on Drug Abuse. 

The results can be tragic. More than 47,000 Americans died of a drug overdose in 2014—more than during any other year on record, according to a new report released last week from the Centers for Disease Control and Prevention.

The number one culprit? The same painkillers that some people don't keep locked up. In fact, the CDC report found that overdose deaths from prescription pain relievers, which have skyrocketed in the last decade, also reached record highs—up 9 percent in 2014 alone.

“Leaving narcotic drugs unsecured is like having a loaded gun lying around,” says Marvin M. Lipman, M.D., Consumer Reports' chief medical adviser, noting that when it comes to prescription pain relievers, there’s little margin for error. Using someone else’s medication, taking too much, or combining it with the alcohol or certain other medications can be a fatal mistake. 

Safer Strategies for Dealing With Prescription Painkillers

“You may not think anyone would get into your medication, but you’d be surprised,” says Lipman. “It could be anyone from an inquisitive youngster to someone seeking the drugs to sell or for recreational use.”

Teens who have abused prescription medications, for example, cite friends and their parents' medicine cabinet as the most common sources for the drugs.

Lipman advises taking two steps for safer, more responsible handling of narcotic drugs at home.

Lock them up. Secure prescription pain relievers and all other medications up and out of sight of visitors and children in a locked cabinet or container. Don’t keep loose pills in bags or containers in your purse, luggage, or office drawer and, when you travel, keep medications in a locking case.

Discard unused pills properly. You can take unwanted medication to drop-off spots at pharmacies, hospitals, clinics, and long-term care centers any time of the year, with no appointment needed. Or you can mail it in to collection centers in special envelopes that are available from pharmacies and other designated locations. To find out where to drop off pills or pick up a mailer, call the DEA’s Registration Call Center at 800-882-9539 or go to deadiversion.usdoj.gov and search for “drug disposal.”

If there’s no drop-off spot in your area and you don’t want to use the mail-back option, the Food and Drug Administration recommends flushing them down the toilet. That’s usually a bad idea because of the possibility of contaminating the water supply and possibly harming aquatic life. But the danger of someone accidentally getting his or her hands on opioids make flushing an acceptable option if you have no other choice.

Taking leftover pills from an old prescription can be dangerous. Read more surprising facts about prescription pain relievers.

Editor's Note: These materials were made possible by a grant from the state Attorney General Consumer and Prescriber Education Grant Program, which is funded by a multistate settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin (gabapentin).

New Packaging Law Aims to Protect Kids From E-Cig Liquid Nicotine Exposure

Poison-control centers last year received more than 3,000 

reports of exposure  to these dangerous liquids

Consumer Reports / Lauren Cooper/ January 28, 2016

President Obama today signed into law a bill that requires child-resistant packaging for liquid nicotine containers used for e-cigarettes and other vaping devices.

Liquid nicotine, used in battery-operated vaping devices such as e-cigarettes and vape pens, is extremely dangerous. One teaspoon is potentially lethal to a child, according to the American Association of Poison Control Centers.

Poison-control centers last year received 3,067 exposure reports across all age groups. In 2014, poison-control centers responded to 3,783 e-cigarette and liquid nicotine exposure cases. More than half of those involved children under age 6 who might have ingested or inhaled liquid nicotine or gotten it on their skin or in their eyes. In December 2014, a 1-year-old boy from Fort Plain, N.Y., died after ingesting liquid nicotine.

Consumers Union, the policy and advocacy arm of Consumer Reports, supported the Child Nicotine Poisoning Prevention Act since its introduction in January 2015 by Senator Bill Nelson (D-Florida), Senator Kelly Ayotte (R-New Hampshire), and 20 other senators.

E-cigs and related devices have been on the market for only about a decade, and experts are still evaluating many aspects of their safety. But “the danger that liquid nicotine poses to young children is undeniable,” says William Wallace, a policy analyst for Consumers Union, which partnered with the American Academy of Pediatrics, the Consumer Federation of America, and Kids In Danger to help educate lawmakers about the threat of young children being poisoned by liquid nicotine.

“Coming in a variety of bright colors and in flavors like cotton candy and gummy bear, liquid nicotine refills used in e-cigarettes have found their way into the hands of children across the country, causing serious and even deadly health consequences.” says Kyran Quinlan, M.D., chair of the American Academy of Pediatrics' Council on Injury, Violence, and Poison Prevention.

Under the new law, liquid nicotine can only be sold in child-resistant bottles and containers packaged in accordance with the Consumer Product Safety Commission's standards. That means that they must meet the same standards as other potentially poisonous household substances as set forth in the Poison Prevention Packaging Act of 1970. Among other stipulations, the law requires that the packaging must be difficult for children under 5 years old to open. Manufacturers have six months to comply.

The American Vaping Association agrees that requiring child-resistant packaging makes sense.

“Parents are recognizing that these products should be kept away from children,” says Gregory Conley, president of the organization. “Requiring child-resistant caps on e-liquid products is a reasonable regulation and is already the law in fifteen states,” he says, adding that, “The Child Nicotine Poisoning Prevention Act [brings] uniformity across all 50 states on this issue."

Next up: preserving the FDA’s ability to regulate e-cigarettes, which is under threat by some members of Congress.

“The new law helps address a known safety risk to children, but e-cigarettes have not been around long enough for us to know the long term effects of using them. It’s critical that the FDA retains the ability to address additional health risks that may emerge with these untested products,” Wallace says.

FDA Creates the Office of Dietary Supplement Programs and Announces New Nutrition Office Leadership

FDA Creates the Office of Dietary Supplement Programs and Announces New Nutrition Office Leadership

December 21, 2015

The U.S. Food and Drug Administration is announcing today the creation of the Office of Dietary Supplement Programs (ODSP), elevating the program from its previous status as a division under the Office of Nutrition Labeling and Dietary Supplements. The FDA is also in the process of identifying permanent leadership for ODSP. In the meantime, Bob Durkin continues to serve as Acting Office Director.

In the 20 years since the establishment of the dietary supplement program, the industry has grown from about $6 billion to more than $35 billion in annual sales. Elevating the program’s position will raise the profile of dietary supplements within the agency, and will enhance the effectiveness of dietary supplement regulation by allowing ODSP to better compete for government resources and capabilities to regulate this rapidly expanding industry.

In the last several years, the FDA has taken numerous actions on dietary supplements to protect public health. The Office of Dietary Supplements Programs will continue to utilize its current authorities and available resources to monitor the safety of dietary supplement products by continuing to:

•  Take action to remove from the market supplement products that are dangerous to consumers;
•  Work with FDA’s Center for Drug Evaluation and Research to help remove from the market products falsely labeled as dietary supplements that contain potentially harmful pharmaceutical agents;
•  Enforce the dietary supplement good manufacturing practices (GMP) regulation, giving priority to cases in which GMP violations:
  •  Potentially compromise product safety;
  •  Fail to ensure product identity, potentially jeopardizing consumer safety; and
  •  Result in  consumer deception, when, for example, manufacturers do not verify the identity of their raw materials.
•  Take action against claims in cases involving serious risk of harm to the consumer (such as egregious claims of benefit in treating serious diseases) or widespread economic fraud. 

As a result of the transition announced today, ODSP’s former parent office will now be known as the Office of Nutrition and Food Labeling, under the leadership of Doug Balentine, Ph.D., who joined FDA on December 14, 2015. Dr. Balentine has a Ph.D. in food science and nutrition from Rutgers University. As the head of the Office of Nutrition and Food Labeling, Dr. Balentine will oversee the development of policy and regulations for nutrition labeling and food standards, infant formula and medical foods. Dr. Balentine brings a wealth of knowledge and expertise to this position.

For more information:

•  What's New in ‎Dietary Supplements
•  Questions and Answers on Dietary Supplements
•  FDA 101: Dietary Supplements

FDA to complete phase-out of chlorofluorocarbon inhalers

FDA NEWS RELEASE

For Immediate Release: Oct. 23, 2013
Media Inquiries: Morgan Liscinsky, 301-796-0397, morgan.liscinsky@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA to complete phase-out of chlorofluorocarbon inhalers

The U.S. Food and Drug Administration will complete its phase-out of all inhaler
medical products containing chlorofluorocarbons (CFCs) by Dec. 31, 2013.
This effort is to comply with an international treaty to protect the ozone layer
by phasing out the worldwide production of numerous substances, including CFCs,
which contribute to ozone depletion.

While most inhaler products containing CFCs have already been phased
out by the FDA, two products currently remain on the market: Combivent
Inhalation Aerosol and Maxair Autohaler. However, these products will no
longer be available after the end of this year. People with asthma or chronic
obstructive pulmonary disease (COPD) who use these inhalers should talk
to their health care professional about a prescription for an alternative treatment.

Inhalers are critical products for those persons suffering from asthma or COPD.
In the United States, more than 25 million people suffer from asthma, a disease
that affects the airways in the lungs and can cause coughing, trouble breathing,
wheezing and tightness or pain in the chest. Additionally, 15 million people have
been diagnosed with COPD, a serious lung disease that worsens over time.
Symptoms can include chest tightness, chronic cough and excessive phlegm.

“CFCs were used as propellants to move the drug out of inhalers so that patients
can inhale the medicine,” said Badrul Chowdhury, M.D., director of the Division of
Pulmonary, Allergy and Rheumatology Products in the FDA’s Center for Drug Evaluation
and Research. “For more than two decades, the FDA and EPA have collaborated
to phase-out CFCs in inhalers – a process that included input from the public,
advisory committees, manufacturers, and stakeholders.”

Most inhalers that used CFCs have already been phased out by the FDA.
The inhaler that was most widely used—albuterol CFC inhaler—was phased
out in 2008 and replaced with inhalers that use propellants called hydrofluoroalkanes
(HFAs). There are many safe and effective inhalers available to treat asthma and
COPD symptoms. All of these inhalers require a prescription, which must come
from a licensed health care professional (a physician, physician’s assistant or
 nurse practitioner).

“The EPA and FDA's partnership has facilitated a safe, gradual transition
to CFC-free inhalers in the United States,” said Drusilla Hufford, director
of EPA’s Stratospheric Protection Division of the Office of Air and Radiation.
 “This action is an important contribution to the global effort to repair the
Earth’s protective ozone layer and save millions of lives through the
prevention of skin cancer.”

CFCs damage the ozone layer, a thin, outer layer in the stratosphere
that acts as earth's shield against the sun's radiation. The United States
and most other countries signed an agreement in 1987 called the Montreal
Protocol on Substances that Deplete the Ozone Layer to phase out the
worldwide production and use of CFCs. In the United States, CFCs have
been removed from such products as hairsprays, deodorants and air conditioning.

For more information:

• Phase-Out of CFC Metered-Dose Inhalers
• Drug Treatments for Asthma and COPD that Do Not Use CFCs

Friday's BBD DigitalHealth Finds: Rating docs bad for your health? A hearing aid iPhone app. Is text4baby beneficial to moms-to-be?

Have you seen the FDA’s new Patient Network website? [FDA]

The website is an interactive tool for educating patients, patient advocates, and consumers on how their medications – both prescription and over-the-counter ­–and medical devices move from the realm of idea to the realm of the marketplace. It will open new channels of communication with the public, such as live chats with senior agency officials. It will help patients and consumers better understand the process for determining whether medical products are safe and effective and encourage them to contribute their ideas and concerns about the development and regulation of these products.

Social network offers discreet way to share health info publicly [Med City News]
A neurologist has started a healthcare social network called HealthKeep that he describes as the inverse of Facebook. Everyone is anonymous but their information is public. It was developed to help serve the 72 percent of Internet users who look for health information, most of whom rely on search engines. And though Facebook is a popular social network, most people wouldn’t feel too comfortable sharing potentially embarrassing personal health queries. This is how it works.

Study demonstrates efficacy of text4baby program [Fierce Mobile Healthcare]
A year-long evaluation of text4baby, a free mobile information service designed to promote maternal and child health through text messaging, has found the program to be effective, according to an announcement of the results. The survey results “indicate that text4baby is increasing users' health knowledge, facilitating interaction with health providers, reminding them of their appointments and immunizations, and improving access to health services.” Among the findings:

New app turns smartphone into hearing aid  [AARP International]
With everyone so “plugged in” to technology these days, researchers at the University of Essex of the UK have created an IPhone App that would allow users to turn their smartphone into a hearing aid. This app is currently available as a beta version and can be downloaded for free through the Apple Itunes Store. The app is currently in a trial period and the creators are hoping to make some fine tuning changes based on feedback from those who choose to download and test out their product. The app is fairly simple to navigate and offers different options for users to choose from, distinguishing it from a traditional hearing aid.

Can personal health data motivate behavioral change? It depends. [MobiHealth News]
One of the critical questions within the connected healthcare movement is whether or not personal health data will actually catalyze and then incentivize lasting behavioral change and better wellness. Will any kind of data serve to motivate behavioral change? Does it matter if we see our data on a smartphone versus a laptop screen? Do all people respond in the same way? Early on, we realized that our ability to transcend our customer base, from highly-engaged, “quantified self” early adopters to the mainstream world of the “frustrated sleepers”, would require far more than just the raw data itself. It turns out that the gift wrapping matters as much as the present inside.

Smartphone app gives doctors remote viewing powers [MIT Technology Review]
At the Forsyth Medical Center in Winston-Salem, North Carolina, nurses can see into the lives of some diabetes patients even when they’re not at the clinic. If a specific patient starts acting lethargic, or making lengthy calls to his mom, a green box representing him on an online dashboard turns yellow, then red. Soon, a nurse will call to see if he is still taking his medication. This novel way of keeping tabs on patients is one of several studies of an app called Ginger.io taking place at hospitals in the United States.

Why rating your doctor is bad for your health [Forbes – published in Jan. 2013]
Suffering from a toothache, a South Carolina woman headed to her local emergency room a few months ago. The doctor there responded by administering Dilaudid, a powerful intramuscular narcotic typically reserved for cancer-related pain. Why, his nurse queried, was he killing a flea with a sledgehammer? Afraid of malpractice? No, the doc replied, Press Ganey. “My scores last month were low.” Press who?

The Most Serious Kind Of Drug Recall Is Increasing

http://www.pharmalive.com/the-most-serious-kind-of-drug-recall-is-increasing/

A reminder that a class I designation means there's a reasonable probability of causing serious adverse health consequences or death.

Posted Thu, 05/16/2013 - 11:27am by Ed Silverman 1

Amid an FDA crackdown on manufacturing violations and a rising shortage of many prescription drugs, it may not be surprising to learn that there were also more recalls during the first quarter of this year.

Specifically, there were 107 recalls, which amounted to a 32 percent increase from the previous quarter and a higher number, on average, according to a report from Expert Recall, a consulting firm.

And given the increased scrutiny placed on compounding pharmacies by the FDA in the wake of the nationwide outbreak of fungal meningitis last fall, a compounder set the record for most recalls in this year’s first quarter with a total of 13.

Overall, there more than 13.1 million unit recalls, up from 11.7 million in the fourth quarter of 2012. The bulk were due to several large recalls, including that involved more than 1 million units each.

Interestingly, there were 14 Class I recalls this past quarter, which was more was document in each quarter of 2012. This is the most serious because these suggest what the FDA calls a reasonable probability that use or exposure will cause serious adverse consequences or death.

Similarly, there were more Class II and Class III recalls in the recently ended quarter than in each quarter during 2012. The number of Class II recalls amounted to 62 and the number of Class III recalls totaled 31.

In a further breakdown, six recalls involved over-the-counter medicines and three “high volume” products accounted for 85 percent of the total. The drugs, however, were not named.

The remainder of the 107 recalls involved prescription drugs, including 14 that were documented as Class I, 61 were Class II and 26 were Class III. And 67 recalls affected US customers nationwide. Only one recall affected customers outside the US.

Here is the report link:
http://www.expertrecall.com/wp-content/uploads/Q1-2013_Pharmaceutical-Recalls.pdf

Recall of all sterile drug products by Med Prep Consulting in NJ

FDA alerts health care providers of recall of all sterile drug products by Med Prep Consulting in New Jersey


The U.S. Food and Drug Administration is alerting health care providers and patients of a voluntary nationwide recall of all lots of all products produced by Med Prep Consulting Inc. of Tinton Falls, N.J, a specialty pharmacy licensed by the state of New Jersey. The recall was announced after health care providers at a hospital in Connecticut observed floating particles, later identified to be a fungus, in five bags of magnesium sulfate intravenous solution.

The magnesium sulfate products may have been distributed to additional facilities in Connecticut, New Jersey, Pennsylvania, and Delaware. Until further notice, health care providers should stop using all products made by Med Prep Consulting Inc. and return them to the company.

“Giving a patient a contaminated injectable drug could result in a life-threatening infection,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “We do not have reports of patient infections. However, due to a lack of sterility assurance at the facility and out of an abundance of caution, this recall is necessary to protect patients.”

This investigation is ongoing. The FDA is working with the Centers for Disease Control and Prevention and state officials in New Jersey and Connecticut to determine the scope of the contamination. The level of recall is to the user level, this includes regional hospital pharmacies and related departments, and physician’s office practices. This recall includes all products distributed through March 15, 2013.

In addition to the recall, on March 15, 2013, the New Jersey State Board of Pharmacy entered into an Interim Voluntary Consent Order with Med Prep Consulting Inc. Under the Order, the firm has temporarily halted all production operations, including the processing and shipping of medications.

Med Prep Consulting Inc. prepares a number of sterile products for intravenous administration for a number of medical conditions. The firm’s products include antibiotics, general and local anesthetics, cardiac, labor and delivery and pain management medications.

To date, the FDA is not aware of any reports of injury or illness associated with the recalled magnesium sulfate intravenous solution. The FDA asks health care professionals and consumers to report any adverse reactions to the FDA’s MedWatch program:

Complete and submit the report online at www.fda.gov/medwatch/report.htm