Congress is on the verge of completing work on legislation to renew the Prescription Drug User Fee Act, which establishes the rules under which private companies pay fees to support the Food and Drug Administration’s process for reviewing their drug applications.
Under the legislation, pharmaceutical, medical-device, and biotech companies would agree to pay at least $6 billion in user fees over the next five years to help fund the FDA’s work on reviewing submissions for safety and efficacy. The fees provide more than half of the FDA’s budget, and without them, getting new drugs and devices to patients likely would be significantly delayed.
Both houses of Congress have passed user-fee bills out of committee with strong bipartisan agreement but with some difference between the two versions. They hope to complete work in ironing out differences by the end of June.
But the rush to complete work always opens the gate to mischief. This time is no different.
Tucked into Section 1131 of the Senate bill is a provision that would require the creators of some new biopharmaceuticals to provide supplies of their drugs to generic competitors, but without the patient safeguards required of the brand-name companies.
This misguided policy relates to an obscure provision called the Risk Evaluation and Mitigation Strategies (REMS) guidelines. The FDA may determine that REMS information is necessary to ensure that the benefits of a drug or biological product outweigh its risks. Products with REMS requirements mean the developer must provide information to doctors, pharmacists, and patients to help manage a known or potential serious risk associated with the drug or biologic. A REMS may warn, for example, that a biologic be avoided by women who are pregnant to protect against possible birth defects.
The current PDUFA legislation would require biopharmaceutical developers to supply REMS drugs to generic manufacturers when the FDA deems it necessary. Failure to do so could expose the developer to fines and potential criminal penalties. But patients could be at risk because generic manufacturers may not comply with the same requirements for REMS notifications as do the brand-name companies developing the drug or biologic.
This provision also faces a potential constitutional challenge. Such FDA intrusion into the marketplace would be unprecedented because the government would be compelling a commercial transaction between companies that does not involve a willing seller and willing buyer.
The REMS provision is expected to save the government at least $100 million over ten years (for reasons that are unclear even to careful observers). The risks to innovation and patient safety are incalculably larger.
It would be reckless for Congress to even consider this provision without a complete congressional examination of the many potential adverse consequences for innovation and drug safety.
The House would be wise to reject the Senate REMS provision in the final bill to avoid this assault on patient safety and the principles of competition.
Posted on National Review Online: Critical Condition, June 17, 2012.