House passes FDA Reform Act

The U.S. House of Representatives today passed its Food and Drug Administration Reform Act by a 387-5 vote.

The bill reauthorizes and expands a user-fee program for drugs and medical devices. The legislation also is designed to help prevent drug shortages, accelerate federal approval of generic drugs and speed up reviews of breakthrough therapies for life-threatening diseases.

The House approval came 6 days after the Senate approved similar legislation by a 96 to 1 vote.

The House and Senate now must reconcile relatively minor differences between the two measures before forwarding the legislation to the White House for President Obama’s approval.

Provisions in the House and Senate versions of the legislation would require drug makers to notify the government about potential drug shortages, including when they plan to discontinue or interrupt production. The federal government would have the ability to alleviate shortages by finding new suppliers, either within the country or overseas.

Dale Shepard, MD, PhD, an associate staff physician in solid tumor oncology at Taussig Cancer Institute at Cleveland Clinic, called the congressional action “a start” but expressed concern that the legislation does not go far enough or address the underlying problems that trigger shortages.

For example, profit margins on several drugs are small, Shepard said.

“If a company tells the FDA, ‘We’re not making enough money on this drug, so we’re going to stop making it,’ what is the incentive for someone else to make it?” Shepard said. “The very reasons one company may discontinue production aren’t going to make it attractive for someone else to pick up the slack, and there is still a shortage. How are you filling that shortage? We know about it, but what can we do about it?”

Drug shortages reached record highs in recent years. The number of drug shortages tripled, from 61 in 2005 to 178 in 2010, according to an FDA report released last fall. An estimated 230 to 270 drugs went into shortage last year.

Oncology has been particularly hard hit.

In January, a survey of 204 oncologists conducted by National Analysts Worldwide revealed that about 80% of respondents had been “unable to provide some patients with appropriate or timely treatment due to drug shortages.” Nearly 50% of respondents reported observing tumor recurrence and 40% reported observing early death among their patients due to shortages.

The legislation would give hospitals the ability to redistribute medication within their own networks, an action prohibited under current law.

“I think that [provision] — the ability to actually utilize the drugs you have — certainly helps patients,” Shepard said.

The legislation would require drug makers and medical device companies to pay $6.4 billion over 5 years to help cover the costs incurred by the FDA during its review of their products.

The measure also would introduce fees for the review of generic drugs and less expensive versions of biotechnology products. The generic drug fees are expected to reduce review times to a third of current levels and improve the availability of generic products for patients, according to sponsors of the legislation.

The Congressional Budget Office said the bill would allow for earlier marketing of lower-cost drugs, which would reduce the average price of drugs on the market. The CBO also estimated the legislation would save more than $750 million over 10 years in Medicaid, Medicare and federal subsidies for private insurance.