Consumers Union Urges FTC to Investigate Mylan for Possible Antitrust Violations

Reprinted from CONSUMERS UNION
POLICY & ACTION FROM CONSUMER REPORTS
www.consumersunion.org

Wednesday, September 7, 2016

WASHINGTON, DC – Consumers Union, the policy and mobilization arm of Consumer Reports, today sent a letter urging the FTC to investigate Mylan for possible anti-competitive practices and antitrust law violations, noting troubling reports of Mylan’s efforts to undercut EpiPen competitors and suppress consumer choice.

Consumers Union describes the five-fold price hike of EpiPen as a “calculated decision by Mylan to exploit its monopoly power to enrich itself and its executives at the expense of the millions of consumers who use this life-saving drug and delivery system as a failsafe,” after a review of the situation produced no legitimate justification for the rapid price hikes. While the letter notes that taking advantage of a marketplace monopoly does not, by itself, violate antitrust laws, the consumer group calls into question several examples of Mylan potentially running afoul of the law.

“It is a violation for a company to maintain its monopoly power by sabotaging or undercutting efforts by competitors to give consumers a choice,” said George Slover, senior policy counsel for Consumers Union. “There are indications that Mylan may have resorted to questionable practices to block competition and sustain its monopoly. The FTC has the authority to prosecute anticompetitive marketplace abuses and we urge the Commission to thoroughly investigate and take appropriate action based on what it uncovers.”

New York Attorney General Eric Schneiderman yesterday announced an investigation into Mylan’s practices and Senators Klobuchar and Blumenthal have also called on the FTC to investigate the company’s conduct.

Visit ConsumersUnion.org to read the full letter.

Consumers Union is the policy and mobilization arm of Consumer Reports.  Consumers Union works for health reform, food and product safety, financial reform, and other consumer issues in Washington, D.C., the states, and in the marketplace. Consumer Reports is the world’s largest independent product-testing organization.  Using its more than 50 labs, auto test center, and survey research center, the nonprofit rates thousands of products and services annually.  Founded in 1936, Consumer Reports has over 8 million subscribers to its magazine, website, and other publications.

A Generic EpiPen Might Not Be Your Best Option

Consumer Reports / Teresa Carr / August 30, 2016

Mylan is introducing a generic version of its life-saving EpiPen, 

but Consumer Reports has found another low-cost option

Mylan's plan to introduce a generic version of its life-saving EpiPen will cut the price in half, to $300 for a two-pack. But Consumer Reports has found that another low-cost option already exists.

Mylan announced the generic version of EpiPen after members of Congress as well as Consumers Union, the policy and mobilization arm of Consumer Reports, called for the manufacturer to lower the $600 price.

The generic EpiPen will be released in the next several weeks. But that's not your only—or perhaps even the best—option for getting the medicine and auto-injector.

There's already a low-cost epinephrine auto-injector available, the generic version of Adrenaclick. This product delivers the same drug, in the same dosages, but the auto-injecting mechanism works slightly differently.

It lists for about $450 for a two-pack, but we found that you could get it for as low as $140 at Walmart with a coupon from GoodRx.com. Your insurance might also cover it with a lower co-pay than brand-name EpiPens, and you might qualifty for further discounts using coupons through the manufacturer.

Mylan says that their new generic will be identical to their brand-name EpiPen. The generic device for giving yourself an injection with the drug ephinephrine will work exactly the same way to quell severe allergic reactions that interfere with breathing. And, like the brand-name version, the generic will be available in two doses—a 0.3 mg adult strength and a 0.15 mg strength for children.

Mylan told us that generic EpiPen will be available from pharmacies and directly from the company by mail.

Generic EpiPen Might Not Be Cheaper For You

With little competition and many years left on the patent for the EpiPen injector, it's "highly unusual" for Mylan to come out with a generic product to essentially compete with itself, says Stephen W. Schondelmeyer, Ph.D., Pharm.D., a professor of pharmacy economics at the University of Minnesota. "I think the company realized that they overreached on price," he says. "They can cut the price in half and still make a profit."

Even so, the generic EpiPen is overpriced, he says. "We're talking about a lifesaving product that costs a few dollars to make," says Schondelmeyer. "It's hardly a consumer win that the company has now decided to charge only $300."

Mylan told Consumer Reports that it won't offer coupons for the generic EpiPen, so even after it hits the market, some people might find it cheaper to stick with the brand-name version, says Barbara Young, Pharm.D., of the American Society of Health-System Pharmacists. "It really depends on your individual situation and insurance coverage," she says.

Young advises enlisting your pharmacists' help in pricing the various options—if possible before your healthcare provider writes the prescription. "Your doctor will need to write the prescription specifically for the device you decide on," she says.

For an EpiPen or generic EpiPen, your healthcare provider can simply prescribe the brand-name product. The generic is exactly the same, so pharmacists should be able to substitute it for the brand if you request it. To help lower the consumer's out-of-pocket costs if they are insured, Mylan announced last week it would offer larger discounted co-pay coupons, up to $300, and it expanded its patient assistance programs for brand-name EpiPens. However, those discounts are not available to people with Medicare or other government health insurance programs.

For generic Adrenaclick, your provider should prescribe "generic Adrenaclick" or simply "epinephrine auto-injector." Because those auto-injectors are slightly different than EpiPens, laws in many states prohibit phamacists from substituting one device for the other. (In some states, however, including California, Colorado, Connecticut, Florida, Vermont, and Washington, pharmacists can fill an EpiPen prescription with generic Adrenaclick, according to the drug's manufacturer, Impax Laboratories.) Just make sure that you get trained on the device before leaving the pharmacy, Young says. EpiPens and Adrenaclick pens are very easy to use and have similar instructions, but you want to make sure that you understand exactly what to do in an emergency situation.

More Competition on the Way

One reason Mylan might be coming out with a generic now is to get ahead of the competition. Earlier this year, the Food and Drug Administration turned down an application by drugmaker Teva for a generic epinephrine auto-injector due to "major deficiencies," but the company told us that it might reapply and that its product could enter the market next year.

In addition, Mark Baum, the CEO of Imprimis, a company that compounds drugs, told us that Imprimis is investigating selling epinephrine auto-injectors directly to consumers for about $100 for a two-pack of pens. Baum noted the company plans on selling them by the end of the year.

In the short term, an array of different options could make it more confusing for consumers, Young says. "But in the long run, the competition is likely to help bring down costs."


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).