Bill Proposes Overhaul of FDA Safety Process

By Diedtra Henderson, The Boston Globe

Jun. 21–WASHINGTON — The Food and Drug Administration would get needed funding to shore up drug safety and patients and doctors would learn more about the risks of new drugs under the most sweeping overhaul of the FDA proposed in 30 years.

The proposal, which would fund many of the changes by increasing fees charged to drug makers, would also give companies better guidance about what would be expected of them if safety problems arose after drugs reached the market.

The proposal, sponsored by Senators Edward M. Kennedy, Democrat of Massachusetts, and Michael B. Enzi, Republican of Wyoming, comes nearly two years after Merck & Co. took Vioxx off the market after the company found it doubled the risk of heart attacks and strokes.

Despite red flags raised early in the painkiller’s development, the FDA had to negotiate for months to add cardiovascular warnings to the Vioxx label. Meanwhile, Vioxx prescriptions soared, aided by aggressive drug advertising. Merck now faces about 13,000 lawsuits related to Vioxx.

Congressional staffers familiar with the draft said yesterday that it was crafted to give regulators more tools to evaluate such safety problems. It would give the FDA power to silence drug advertising for up to two years, and it would create stiff penalties for drug firms that fail to follow through on post-marketing safety studies.

“It’s critical that the FDA be given the ability to ensure that the risks of prescription drugs are adequately assessed and managed, so that drugs can be safely used by patients,” Kennedy said.

Drug companies already pay user fees to the FDA — $320.6 million are proposed in the fiscal 2007 budget for prescription drugs alone — to speed the agency’s review of new drugs. The bill is being reworked before it is introduced before the August recess, but the higher fees it would demand have already drawn criticism.

“There are important things to do on the drug safety front, and they cost money. And we’re for that. But we’re not for continuing to have … fees grow and grow and grow if there is not a commensurate” increase in congressional funding for the FDA, James C. Greenwood, president of the Biotechnology Industry Organization, said last week in Boston.

Daniel Troy, a former FDA chief counsel who now represents drug companies in private practice, said user fees are “metastasizing” into a vehicle for the industry to shoulder more of the agency’s costs.

“That wasn’t the deal. The original prescription drug user fee deal is we would pay for the time, effort, energy and money that you spend reviewing our application,” Troy said. “Pretty straight forward.”

The Kennedy-Enzi bill proposes to place much of the FDA drug-safety improvements within that premarket review covered by the fees. But it would also give the agency more flexibility to manage saftey problems after drugs are approved, and some drug makers would be required to conduct large clinical trials after approval.

Failure to conduct such studies could trigger speedy and costly responses. Under the bill, the FDA could seek injunctions to block drug sales. It could also seek criminal penalties in court or civil penalties through an administrative processes.

To eliminate time-consuming negotiations before adding warnings to the drug label, drug companies could turn to the FDA’s Drug Safety Oversight Board to referee such disputes.

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