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WSJ – House Passes FDA User Fee Reauthorization

WSJ – House Passes FDA User Fee Reauthorization


The House on Wednesday passed a bill to let the Food and Drug Administration collect about $6 billion in user fees from medical companies to help fund the agency.

The bill, passed in a bipartisan majority voice vote, is expected to reach a final vote in the Senate next week.

The $6 billion in fees would be paid over five years by the brand-name and generic drug industries and the medical-device industry. The legislation’s approval of fees from generic companies and from companies that make generic-like “biosimilar” knockoffs of complex and expensive medicines also would be new if the law, as expected, wins approval in the Senate.

The bill passed by the House will give the FDA new powers to compel inspections of overseas drug facilities in foreign countries, such as China and India, where the bulk of raw materials for drugs are produced. It would give the agency power to block products’ entry into the U.S. if the FDA were refused admission to conduct full inspections, and gives the FDA broad discretion to conduct more inspections overseas.

The legislation also calls for quicker agency approval of drugs deemed breakthrough medications that could be lifesaving or for serious illnesses. It also includes certain targeted incentives for the production of new antibiotics.

The bill also requires drug makers to notify the FDA early of any expected shortages of drugs, a problem that has worsened in the U.S. in recent years. FDA officials have said in congressional hearings that in many cases they weren’t notified of such impending shortages until it was too late to prevent them.

A final version of the bill is expected to be ready for President Obama’s signature by the July 4 congressional recess.