Democrats’ Bill Would Boost FDA Drug Industry Oversight
Democratic lawmakers this week introduced bills that would reform FDA and boost regulation of prescription drugs, the Wall Street Journal reports.
On Thursday, Sens. Edward Kennedy (D-Mass.) and Michael Enzi (R-Wyo.) introduced a bill (S 484) that would boost FDA's oversight authority by requiring drug approvals to be paired with programs to manage risk once they reach the market. These programs could include mandatory post-market safety studies, restrictions on which providers can prescribe or dispense a drug, or a moratorium on direct-to-consumer advertising for newly-approved drugs. The Kennedy-Enzi bill also would require all clinical trials to be registered and their results stored in a public database.
Rep. Henry Waxman (D-Calif.) has said he plans to introduce a drug safety bill similar to the Kennedy-Enzi bill in the House. Waxman also plans to introduce legislation that would allow generic versions of biotech drugs, which would provide significant competition for the costly brand-name versions of the drugs.
Meanwhile, Sens. Chris Dodd (D-Conn.) and Charles Grassley (R-Iowa) on Wednesday introduced legislation (S 467) that would restructure FDA to create a center to oversee drug safety post-approval.
The Journal notes that a "ready-made vehicle" for changes in drug regulation and FDA authority is the user-fee agreement between drug companies and the agency, which provides much of the funding for FDA's drug-review process. The user-fee agreement -- under which drug companies pay fees to FDA in exchange for quicker reviews of new drug applications -- expires this year.
Lawmakers are not in agreement over whether regulatory legislation should be linked with the user-fee agreement, according to the Journal.
Rep. John Dingell (D-Mich.), chair of the House Energy and Commerce Committee -- which has jurisdiction over FDA -- said he does not want to "bog down" the user-fee bill with additional provisions. If Congress does not pass the user-fee renewal by late summer, "it risks shutting down much of the agency's drug-regulation activity," the Journal reports.
FDA in January announced that it was able to negotiate with the pharmaceutical industry for $393 million in fees for the next fiscal year -- an increase of about one-third over current levels. The increase "would grant the FDA substantially more money for safety monitoring and fund more staff to review pharmaceutical ads," according to the Journal (Wilde Mathews, Wall Street Journal, 2/2).