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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

FBI arrests Turing Pharmaceuticals CEO Martin Shkreli

Business News | Fri Dec 18, 2015 6:34am EST

Related: REGULATORY NEWS, BREAKINGVIEWS

Vilified for drug pricing, CEO Shkreli busted for securities fraud

NEW YORK | BY NATE RAYMOND AND DAVID INGRAM

Martin Shkreli, the boyish pharmaceutical entrepreneur who caused a public uproar after he drastically raised the price of a life-saving prescription drug, was arrested on Thursday for engaging in what U.S. prosecutors said was a Ponzi-like scheme at his former hedge fund and a pharmaceutical company he previously headed.

Shkreli, who has become a lightning rod for growing outrage over soaring prescription drug prices, was arrested before dawn at the tony Murray Hill Tower Apartments in midtown Manhattan. Clad in a grey hoodie, the 32-year old could be seen being escorted by a slew of law enforcement, including FBI, into a car.

It was a dramatic turn of events for Shkreli, who in recent months became a pariah for his controversial remarks in the press and taunts on social media outlets, including to Democratic presidential candidate Bernie Sanders.

Many on social media said Shkreli was getting what he deserved. On Twitter, the top hashtag and keyword related to his arrest was #Karma. But ironically his downfall was not related to expensive drug pricing.

In an odd foreshadowing of events, a video posted last night on his YouTube page shows Shkreli answering a phone call during a live stream in which a caller at 1:22:10 identifies himself as a "special agent" before Shkreli appears to cut him off and hangs up. (here)

Shkreli, who is chief executive officer of Turing Pharmaceuticals and KaloBios Pharmaceuticals Inc (KBIO.O), was charged in a federal indictment filed in Brooklyn relating to his management of hedge fund MSMB Capital Management and biopharmaceutical company Retrophin Inc (RTRX.O).

Brooklyn U.S. Attorney Robert Capers said at a news conference that Shkreli "essentially ran his companies like a Ponzi scheme, where he used each subsequent company to pay off defrauded investors in the prior company."

Authorities highlighted what they called the "brazenness" of his actions. Shkreli's efforts to conceal the fraud led him to use the assets of Retrophin to pay off debts from his hedge funds, Capers said.

Shkreli was charged with securities fraud, securities fraud conspiracy and wire fraud conspiracy. The maximum sentence for the top count is 20 years in prison.

"Mr. Shkreli is confident that he will be cleared of all charges filed by the U.S. Attorney’s Office for the Eastern District of New York (EDNY) and the Securities & Exchange Commission," a representative said in a statement late Thursday.

"(He) also strongly denies the charges regarding the MSMB entities, which involve complex accounting matters that the EDNY and SEC fail to understand," the representative added.

The indictment, the result of an ongoing investigation, also charged Evan Greebel, a former partner at law firm Katten Muchin Rosenman who was Retrophin's outside counsel. Greebel, 42, was also arrested on Thursday.

Shkreli and Greebel entered pleas of not guilty through their lawyers.

Both were also sued in a related lawsuit by the U.S. Securities and Exchange Commission, which also named New York-based hedge fund MSMB Capital Management as a defendant.

Later, a magistrate approved a $5 million bond package, allowing Shkreli to go home after processing pre-trial paperwork. During the bail hearing, unshaven Shkreli was wearing a black V-neck t-shirt with blue jeans. He appeared relaxed, smiling at what appeared to be family members in the courtroom.

When Shkreli left the courtroom, he was mobbed by reporters who shouted questions about the allegations. Shkreli did not answer any questions.

The securities fraud investigation predated a separate controversy surrounding Shkreli since September, when reports surfaced that his privately held Turing had raised the price of Daraprim, a 62-year-old treatment for a dangerous parasitic infection, to $750 a tablet from $13.50 after acquiring it.

Asked if Shkreli raised drug prices to pay back investors, Capers said that was not part of the investigation. "I wouldn't want to speculate on his reasoning for trying to increase the price on those drugs," he added.

Shares of KaloBios fell 53 percent to $11.03 in premarket trade before being halted. Retrophin, which said in a statement that it had fully cooperated with the government investigations of Shkreli, closed down 1.9 percent at $20.94.

Turing and KaloBios declined to comment. Lawyers for Shkreli had no comment.

A lawyer for Greebel did not immediately respond to requests for comment. In July, Greebel had joined the law firm Kaye Scholer, which in a statement noted the "transactions in question predated his arrival to the firm."

RELATED VIDEO

Shkreli charged in "Ponzi-like" scheme

Shkreli treated funds like piggy bank - Columbia Law's Coffee

INTERNET OUTCAST

Social media lashed out at Shkreli over the Daraprim fiasco. He in turn provoked his critics, and was often vocal on Twitter and other online platforms about his business strategies, politics and even musical tastes.

On Thursday, the online social network was buzzing with hashtags #Shkreli and #Karma trending heavily. Many said Shkreli was getting what he deserved and mocked his $2 million purchase of a Wu-Tang Clan album.

In recent days, he even said that journalists do not "matter" and asked about a Democratic presidential candidate, "If @BernieSanders was a parasite what would he be?"

Sanders, who advocates a single payer healthcare system to control drug prices, had refused to accept a donation from Shkreli, instead giving the money to a health clinic in Washington, D.C.

Shkreli has several live stream YouTube sessions. In one, he can be seen sitting at a computer in a plain white room with two electric guitars and an amplifier visible behind him while he answers infrequent questions from viewers.

In a video posted on Wednesday he flippantly referred to “the miserable monotony of being ultra-rich.”

Shkreli is also an avid video game player who uses the handle “Imagine Cerebral,” according to one of his Twitter posts. He is an executive of a team of players, called Team Imagine, which participates in the online multiplayer game League of Legends, according to various media reports.

PONZI-LIKE SCHEME

Thursday's charges relate to Shkreli's management of MSMB Capital Management, whose closure he announced in 2012, and his time as CEO of Retrophin from 2012 to 2014.

The indictment said Shkreli made false representations to MSMB investors to draw in $3 million in investments.

After MSMB suffered devastating trading losses in 2011 and ceased trading, Shkreli for months sent fabricated updates to investors touting profits of as high as 40 percent since inception, the indictment said.

He also solicited $5 million from investors for another fund, MSMB Healthcare Management LP, while concealing his performance managing MSMB Capital and a prior fund and providing investors an inflated valuation of his then-private firm Retrophin, the indictment said.

To pay back the MSMB funds' investors, Shkreli and Greebel misappropriated $11 million in Retrophin assets through settlement agreements and sham consulting deals, according to the indictment.

    The case mirrors a lawsuit Retrophin filed in August against Shkreli in federal court in Manhattan for $65 million, claiming he had used his control over the company to enrich himself and pay off MSMB investors' claims.

Shkreli has denied those allegations.

(Reporting by Nate Raymond and David Ingram; additional reporting by Caroline Humer, Melissa Fares, Angela Moon and Lawrence Hurley; Writing by Bernard Orr; Editing by Ted Kerr, Lisa Von Ahn, Noeleen Walder and Diane Craft)

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Holiday Bill of Rights

Expensive pill to swallow

CBS This Morning
DECEMBER 1, 2015

Consumer Reports investigates prescription drug sticker shock

Americans spent $374 billion on prescription drugs last year, but only 17 percent of people shop around for a lower price. Consumer Reports found that some people spend up to 10 times more than is necessary for common medications. Consumer Reports prescription drug editor Lisa Gill joins "CBS This Morning" to discuss the results of its national survey.

http://www.cbsnews.com/videos/consumer-reports-investigates-prescription-drug-sticker-shock/

No tomorrows

Every word is true except for "dreams for tomorrow." Sadly there are no tomorrows with my daughter. There is NOTHING that will ever stop me from loving Laura. 

Today's pic from FB

David reading his sister a story (1984)

Dixie Landings

Traveling home from Ocean City, MD

Dave is not liking fishing. I think he was afraid of the worms. 

Last night our friend, Bob, posted the fishing pictures on FB. 

I was thrilled to see them. I am sure I have copies in the hundreds of photos I have stored away. These were taken at Dixie Landings in Disney. One of our many vacations in Orlando. 

The Goofy hat is still hanging in Laura's room on the lamp post where she always kept it. 

Years ago when we were in Key West; we spent the day on a large catamaran snorkeling and catching some sun. The three of us had a terrific day together. David was there because he wasn't with us. Laura loved to go on vacations! 

Seven years...and my heart still has a huge hole in it. 

Today & yesterday's photos from FB

Or 25th wedding anniversary. We renewed our vows at Sacred Heart in Newark.
This is a special picture because everyone is smiling (although I am not sure if Joan is smiling)!
Melissa, Danielle Laura, Joan, Trish, Jim, David, me, Fred

 Christmas

Dave's birthday

Senior Prom

Grand Baby

Anyone who was close to Laura knew how much she treasured "Grand Baby." She cuddled with this doll since she was three years old. It went everywhere we did when she was a little girl. Once Grand Baby had her own seat on an airplane going to Florida. Grand Baby went with Laura. 

Birthday flowers

One of Laura's birthday pictures. She loved receiving flowers. I am almost positive the arrangement came from Mrs. B (Michael's mom).

Always friends...

Laura & her best friend, Michael. This was taken when they were in HS. I would guess 9th grade because they both look so young. Laura met Michael in kindergarten and they remained close friends till the day Laura's heart stopped beating. 

Dixie Landing

One of our vacations at Disney (1992). 

Troop 27 memories

Laura & Pat

Pat & I were co-leaders of St John's Brownie troop. Laura was in first grade when she begged and pleaded with me to form a Girl Scout troop at school. I couldn't find anyone from St. John's school who wanted to help me. Girl Scout council hooked me up with a fine lady from St. Therese's school and that was the beginning of many wonderful memories. Our troop stayed together until the girls achieved their silver medal in 9th grade. Needless to say, the years granted us with a lot of fun times. 

Below is a passage I copied from FB the other day:

Thinking of you today, Laura Citarella. You brought such joy and love to our lives and are sorry that you are not here with us today to celebrate another fall day. We know that your work here was done; however, we selfishly feel pain and say, "Laura, you're gone way too soon and have left great pain in our hearts; we loved/ love you!"
We think of you often and see you everywhere we go in Bergenfield, your home town.

We are forever grateful to you for your insistence to have a Girl Scout troop at St. John's because that is how our families met and truly became family.

When we get together and share a meal, Deacon Jim, Jim to you, often remembers you out loud as we pray.

Thank you for all your visits and signs from up above for they keep your family: Fred & Claudia 

We hope that you too are finding great joy in little Emma. She is as beautiful as you were/are. David along with Danielle have become quite good parents.

Laura never doubt, though you have left us to go to Heaven to prepare the way for us all, you are and shall forever remain in our hearts. 

We so Love you!
Feel a warm hug ~

Happy Angel Day Laura!
Until we meet in Heaven,
Aunt Pat

Sand sculpture

This photo was taken in Ocean City, MD. We were on vacation for a week and during that time a sand sculpture contest took place. 

Daddy's girl

We made it through another anniversary thanks to friends' sweet memories and thoughtful texts/calls, mass in memory of our daughter, the family meeting at the cemetery, dinner at D&D's house. And of course, holding and cuddling our granddaughter, Emma Elizabeth, who Laura would have loved and cherished.  

We are grateful for our family and special friends!

Laura & Aunt Joanie

Today's picture in memory of Laura. 

Can't remember what we were celebrating...

birthday, prom, graduation? 
Laura loved receiving flowers. 

Laura & Sierra

For the month of November I will change my FB cover pic everyday to showcase Laura. Check back to see if you are in one of the pictures. 

Today's selection is Laura & Sierra. 

Dumbo

Laura's favorite amusement ride when she was little. When she go older she still insisted on riding Dumbo. 

November...

...the month of our birthdays...the month of  our daughter's death...the month of Thanksgiving. Seven years ago on November 8 our world shattered and will forever be changed; our hearts will always be shattered. 

We miss you Laura Elizabeth