Congress is one step closer to passing legislation that would give the Food and Drug Administration (FDA) more authority in handling approval and monitoring of prescription drugs.
In early May, the Senate passed the Food and Drug Administration Revitalization Act by a 93 to 1 vote. Sponsored by Sens. Edward M. Kennedy (D-MA) and Mike Enzi (R-WY), the bill (S. 1082) mandates drug manufacturers publicly register clinical trials on new therapies. The legislation also requires drugs be monitored after they hit the market.
“Right now, the FDA has its hands tied behind its back when it tries to manage the risks of drugs already on the market,” Enzi said in a news release. “This bill will clarify and strengthen the FDA’s authority, and give it new tools to take measured and appropriate steps to protect the health and safety of Americans when the agency’s post-market surveillance signals potential dangers from a drug therapy.”
At press time the bill was headed to the House for a vote.
The legislation includes Risk Evaluation and Mitigation Strategies (REMS) giving FDA the authority to add warnings to drug labels and oversee safety via access to databases that hold records of harmful events involving prescription drugs. The REMS would also require pharmaceutical companies to create and execute post-marketing surveillance policies for their products. Companies that do not comply with FDA directives would be fined $10,000 to $250,000 per violation.
Kennedy said REMS will help ensure drug safety.
“Safety and better access are at the core of the bill,” Kennedy said in a statement. “It greatly improves the way the FDA oversees the safety of drugs. It recognizes that when patients are in danger, the FDA should not have to wait to get legal opinions to decide how to protect health. It should be able to act immediately, and our bill gives it that authority.”
Critics, however, say the bill does nothing but add a layer of bureaucracy to an already sluggish agency.
“The agency is already fat and lazy and it does not need additional resources,” said Henry Miller, a research fellow at Stanford University’s Hoover Institution, a California-based public policy research center. “Drug safety is not the FDA’s fundamental problem. The problem lies in the fact that the agency is overly risk-averse and overly defensive in its decision making.
“This is the wrong diagnosis and the wrong treatment,” Miller continued. “In terms of the requirement for post-marketing surveillance, the FDA already has the authority to require risk minimization action plans and has access to safety information by way of the Records and Information Management system. This is essentially creating more tools for federal pork.”
Two senators want to go even further than the Kennedy/Enzi bill.
Sens. Charles Grassley (R-IA) and Christopher Dodd (D-CT) reintroduced two bills, S. 467 and 468, which would not only enforce post-market surveillance and expand public access to clinical trial information, but also would create a new office focusing squarely on overseeing drug safety. At press time, both bills were pending in the Senate Committee on Health, Education, Labor, and Pensions after being introduced in January.
Aricka Flowers ([email protected]) writes from Chicago.