FDA Set to Get Broad New Powers

Congress is on the verge of sending President Bush the largest expansion of Food and Drug Administration regulatory powers in a decade, seeking to bolster the monitoring of prescription drugs and medical devices.
Democratic and Republican members of the House Energy and Commerce Committee lauded a compromise reached Wednesday after weeks of negotiations.
“This legislation strikes the proper balance between new drug-safety measures and ensuring consumers have access to innovative prescription pharmaceuticals in a timely manner,” said Energy and Commerce Chairman John D. Dingell, D-Mich., the bill’s primary House author.
The bill marks a success for the Democratic majority. It also would expand labeling, tighten the regulation of drug advertising and give consumers access to information on clinical trials of drugs and medical devices.
The House passed the legislation (HR 3580) by 405-7 under suspension of the rules Wednesday, setting up final action by the Senate to clear the compromise bill. No amendments were permitted under the House’s fast-track procedure, which required a two-thirds majority.
Senate Majority Leader Harry Reid, D-Nev., was checking with senators to determine whether he could clear the legislation on a voice vote this week, Reid’s spokesman said Wednesday evening.
User fees paid by pharmaceutical manufacturers and medical device makers finance FDA reviews of applications to market new products. Unless those fees are reauthorized by Sept. 30, the agency would have to lay off some 2,000 employees. Lawmakers had vowed to complete work on the reauthorization by Sept. 21.
Frank Pallone Jr., D-N.J., chairman of Energy and Commerce’s Health Subcommittee, acknowledged that the bill was not everything the Senate wanted, but he still expected the chamber to clear it.
“I’m not going to say they signed off on it,” Pallone said. But he added, “I’m expecting them to take it up the way it is.”
However, Reid’s attempt to clear the measure by voice vote Wednesday night was blocked by several Republicans who wanted more time to study the 422-page bill, according to a GOP aide.
“It seems a number of senators are objecting because they’re upset that leadership is trying to secretly ram through a Pelosi bill over 400 pages long that no one has even read,” said the aide, referring to House Speaker Nancy Pelosi, D-Calif.
Even the bill’s strongest advocates in the Senate were not entirely happy. “This is not a perfect bill, and compromises were made to assure its passage,” said Edward M. Kennedy, D-Mass. He added: “But after so many recent instances in which Americans have been harmed by unsafe prescription drugs and contaminated food, America cannot afford inaction on this important measure.”
The cornerstone of the package is a reauthorization of the FDA’s drug-approval program, funded by nearly $400 million in drug and device company user fees that finance FDA reviews of applications to market new products.
House and Senate negotiators wrote the legislation from bills (HR 2900, S 1082) the chambers passed earlier in the summer. The drug-safety provisions in the original House bill were considered more far-reaching than those in the Senate measure. The new bill was built on several compromises between the House and Senate versions.
Many of the bill’s drug-safety regulations grew out of problems discovered in widely prescribed drugs that had been approved by the FDA and were marketed to millions of Americans.
One such case involved the arthritis drug Vioxx, which was shown to increase cardiovascular risk and is the subject of hundreds of lawsuits throughout the country.

Major Provisions

Under the compromise, drug companies would pay a new user fee totalling some $225 million over five years that would fund FDA drug-safety activities. The agency could force drug manufacturers to conduct follow-up safety studies after a drug has been approved. The agency would also have the authority to require changes to drug labelling and levy fines for non-compliance.
Direct-to-consumer ads, such as the ubiquitous television commercials for certain drugs, would be more strictly regulated by the FDA. The agency would be able to review drug ads and fine companies for false or misleading ads, but it would not be able to ban them, even temporarily.
The bill discards the idea of a specific limit on the number of waivers allowed for FDA advisory panel members with financial conflicts of interest. Advisory panels, made up of academic researchers and other experts, offer influential guidance to the agency on whether a new drug appears to be both safe and effective enough to warrant approval. Instead, using 2007 as a baseline, the measure would reduce by 25 percent the allowable number of conflicts of interest, which can arise if a panel member has conducted research with grants from a drug company whose product is under review.
House Democrats originally pushed for a limit of one waiver per panel. The Senate bill would have largely preserved current law, which does not put a limit on waivers.
House Democrats also won inclusion of a provision sought by Henry A. Waxman, D-Calif., that would create a public, searchable database of clinical trials for drugs and medical devices. It would include information on safety risks and would be administered by the National Institutes of Health.
Drugmakers that conduct studies on new pediatric uses of drugs would be granted six months of market exclusivity. In the Senate version, so-called blockbuster drugs would have been given only three months of exclusivity.
The final version did not please all Democrats.
“I want to express my deep disappointment that today we’re walking away from our opportunity to adjust the windfall profits that drug companies receive from conducting pediatric studies,” Waxman said.
He said the large profits that drugmakers reap far outweighed the expense of conducting new studies.
First posted Sept. 19, 2007 4:46 p.m.Source: CQ Today