Healthy Skepticism Library item: 10042
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Mathews AW.
Senate Bill Would Boost FDA Powers
The Wall Street Journal 2007 May 10A4
http://setup1.wsj.com/article/SB117873083650997398.html?mod=Health
Full text:
WASHINGTON — The Senate approved legislation that would change how drugs are regulated in the U.S., giving the Food and Drug Administration new powers to restrict medications that raise serious safety concerns.
The 93-1 vote will give the bill, sponsored by Sen. Edward Kennedy (D., Mass.) and Sen. Michael Enzi (R., Wyo.), strong momentum in eventual negotiations with the House over the measure’s final language.
Congress is expected to pass a version of the bill before the fiscal year ends in September because it reauthorizes the user fees the FDA collects from the drug industry and makers of medical devices. Those fees are vital to the agency’s operations.
The House has yet to pass its version, but that, too, is expected to include provisions designed to improve oversight.
John Dingell (D., Mich.), chairman of the House Energy and Commerce Committee, expressed “dissatisfaction” with the FDA’s handling of drug-safety issues and said he favored “structural and resources changes within the agency,” as well as cultural reform. Rep. Henry Waxman (D., Calif.) has introduced a bill that largely mirrors the Senate’s approach.
If it becomes law, the Senate bill, called the Food and Drug Administration Revitalization Act, could shift the balance of power between regulators and the pharmaceutical industry. It requires the FDA to monitor drugs after they go on the market and provides new funding for that job. The bill would also require companies to make public the results from many of their studies.
The measure would grant the FDA authority to take major actions, including requiring new studies, limiting distribution or ordering label changes if the agency thought they were necessary. Currently, the FDA’s authority in that area isn’t clearly delineated, so the agency often has to negotiate with companies, using its leverage before it grants approval for a new drug or the indirect threat of its bully-pulpit power to get the concessions it seeks.
The bill sets up a mediation process for a drug company to use if it opposes an agency restriction, but it leaves the final decision to the FDA.
“We put a bunch of tools in the toolbox for the FDA to be able to do things after a drug is approved,” Sen. Enzi said.
In a victory for the drug industry, the Senate rejected an effort to legalize imports of prescription drugs. Some other elements that the industry opposed, such as restrictions on advertising, were toned down.
Billy Tauzin, who heads the Pharmaceutical Research and Manufacturers of America, said the group was “generally pleased,” but “you don’t want to overwhelm with regulatory requirements” the majority of drugs that don’t have unexpected safety issues.
Sen. Kennedy has said he will add language that would allow the FDA to approve copycat versions of biotechnology drugs, a high-stakes issue. A Democratic staffer on the House Energy and Commerce Committee said it would be difficult to resolve disputes over House versions of generic-biotech-drugs legislation in time to move through the House in tandem with user-fee legislation.
James Greenwood, who leads the Biotechnology Industry Organization, said the group thinks the Senate timing doesn’t leave time for lawmakers to resolve the complex issues.
Because the Senate bill sets user fees through 2012, it is considered must-pass legislation. As a result, it has became a vehicle for various provisions, including limits on petitions that can delay agency approval of generic drugs, new incentives for the development of antibiotics, and renewal of a law to encourage pediatric drug studies.
