Don’t Be Reckless with New Drug Law

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. 


Most Popular

Law & the Courts

Obstruction Confusions

In his Lawfare critique of one of my several columns about the purported obstruction case against President Trump, Gabriel Schoenfeld loses me — as I suspect he will lose others — when he says of himself, “I do not think I am Trump-deranged.” Gabe graciously expresses fondness for me, and the feeling is ... Read More
Politics & Policy

Students’ Anti-Gun Views

Are children innocents or are they leaders? Are teenagers fully autonomous decision-makers, or are they lumps of mental clay, still being molded by unfolding brain development? The Left seems to have a particularly hard time deciding these days. Take, for example, the high-school students from Parkland, ... Read More
PC Culture

Kill Chic

We live in a society in which gratuitous violence is the trademark of video games, movies, and popular music. Kill this, shoot that in repugnant detail becomes a race to the visual and spoken bottom. We have gone from Sam Peckinpah’s realistic portrayal of violent death to a gory ritual of metal ripping ... Read More

Romney Is a Misfit for America

Mitt’s back. The former governor of Massachusetts and occasional native son of Michigan has a new persona: Mr. Utah. He’s going to bring Utah conservatism to the whole Republican party and to the country at large. Wholesome, efficient, industrious, faithful. “Utah has a lot to teach the politicians in ... Read More
Law & the Courts

What the Second Amendment Means Today

The horrifying school massacre in Parkland, Fla., has prompted another national debate about guns. Unfortunately, it seems that these conversations are never terribly constructive — they are too often dominated by screeching extremists on both sides of the aisle and armchair pundits who offer sweeping opinions ... Read More

Fire the FBI Chief

American government is supposed to look and sound like George Washington. What it actually looks and sounds like is Henry Hill from Goodfellas: bad suit, hand out, intoning the eternal mantra: “F*** you, pay me.” American government mostly works by interposition, standing between us, the free people at ... Read More