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FDA Public Meeting Examines Regulatory Abuse and Generic Drug Access

Yesterday, July 18th, the Food and Drug Administration held a very large public meeting at their White Oak campus in Silver Spring to get public input on the Hatch-Waxman amendments and access to generic drugs. Many different individuals and organizations testified that brand drug companies are abusing FDA regulations to delay or block access to generic drugs, and called for action to end these abuses. The three areas are the misuse of REMS protocols, the abuse of citizen petitions, and product hopping.

Director Scott Gottlieb opened the meeting with a statement emphasizing the importance of vigorous competition and praising generic drugs. In too many places people cannot afford their medicines, and generic drugs are literally a lifesaver for many patients. The FDA plays a key if indirect role in influencing drug prices, and its policy should be to encourage access to and development of generic drugs. Gottlieb stated that “abuse of regulations undermine the entire market” and announced that the FDA will soon issue two new documents to streamline the review process. “This does not mean lowering our standards or goals,” he told the crowd. Instead, it will eliminate unnecessary and duplicative procedures.

Academics, consumer groups, patient groups, businesses, and healthcare providers all highlighted regulatory abuses and urged that the FDA stop them. Professor Michael Carrier pointed that in many cases companies make small, insignificant modifications to drugs so they can extend the patents and exclusive periods and make greater profits. Brand companies have labeled their own drugs obsolete (even when they still work fine) and even destroyed their own inventories on occasion. These reformulations harm competition, and consumers ends up paying the price. Citizen petitions are used to delay generic entry—the FDA denies 92% of them, and almost all of the late-filed petitions. The presenters usually concluded with calls from greater testimony. Suggested reforms included more information on citizen petitions and which companies are behind them, publicizing FDA letters that say REMS is not an excuse for delays, and discouraging product hopping.

Brand companies were present as well. They countered that abuses of FDA regulations were greatly exaggerated, that generic drug companies were also at fault, and that citizen petitions performed a vital service and were constitutionally protected. Therefore no reforms were necessary. However, generic companies were also present, and they effectively answered these claims. Regulatory abuse is a widespread and growing problem which the FDA should address.

Most of the presenters also called for Congress to pass the CREATES Act, sponsored by Senator Patrick Leahy (D-VT). The act would forbid a whole bunch of anticompetitive practices and deter brand companies from blocking generic drugs. It is currently before the Senate Judiciary Committee.

David Mitchell, President of Patients for Affordable Drugs, spoke eloquently about high drug prices and his battle with cancer. His group focuses exclusively on lowering drug prices and has collected stories from over 7,000 patients. Mr. Mitchell is a cancer patient with multiple myeloma, and he is taking Revlimid to treat it. The company Celgene is using the REMS protocol as an excuse for not giving out samples to generic drug companies and as a result Mitchell had to pay much higher prices. Fortunately he has good insurance through a good company that covers most of the costs, but a lot of patients are not so lucky. “Life-saving drugs don’t work if people can’t afford them,” he told the panel.

Finally, our own David Balto concluded that when regulations are gamed in order to block generic drugs, that problem cannot be solved by competition. He cited Judge Bork’s quote that “Predation by abuse of governmental procedures, including administrative and judicial procedures, presents an increasingly dangerous threat to competition.” Drug innovation and generic access aren’t opposed, and manipulation of regulations harm competition from other generics. Transparency is the enemy of this malpractice, and the more information that is publically available, the better.

The FDA concluded the meeting and said they will accept written comments for the next two months until the middle of September, and they will take our views under advisement when crafting future policies. This meeting was an encouraging first step toward ensuring that patients can get affordable generic drugs and ending regulatory abuse.

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