FDA To Approve Generic Versions Of Biotechnology Medications
The House Energy and Commerce Health Subcommittee on Wednesday held a hearing on a bill sponsored by Rep. Henry Waxman (D-Calif.) that would allow FDA to approve generic versions of biotechnology medications, CQ HealthBeat reports (Reichard, CQ HealthBeat, 5/2). Companion bills (HR 1038 and S 623) introduced earlier this year by Waxman and Sens. Charles Schumer (D-N.Y.) and Hillary Rodham Clinton (D-N.Y.) would allow FDA to approve "comparable" and "interchangeable" generic versions of biotech medications through an "abbreviated" process. Companies that seek to market comparable generic versions of biotech medications would have to prove that their treatments have active ingredients "similar" to those of the brand-name versions.
Companies that seek to market interchangeable generic biotech medications would have to prove that their treatments have molecular structures "comparable" to those of the brand-name versions and that their treatments have the same effects as the brand-name versions in all patients. The legislation would not specifically require companies that seek to market comparable or interchangeable generic biotech medications to conduct clinical trials. However, the legislation would allow FDA to require trials on a case-by-case basis (Kaiser Daily Health Policy Report, 4/16).
At the hearing, Reps. Tammy Baldwin (D-Wis.), Anna Eshoo (D-Calif.), Gene Green (D-Texas) and Jay Inslee (D-Wash.) -- each of whom represent districts with biotech interests -- criticized the bill. Baldwin said that the legislation would discourage investment in the development of new medications by biotech companies, adding that Congress must "remember those patients who are still waiting for their miracle medications to be discovered." Green said congressional efforts to reform FDA are "disingenuous" in the event that they provide the agency with "blanche authority to approve follow-on biologics without some sort of clinical trial."
Additional Comments
FDA Chief Medical Officer Janet Woodcock did not take a position on the bill but said the agency could approve generic versions of some less complex biotech medications without extensive trials. In addition, she said that future scientific advancements might make trials unnecessary for FDA approval of generic versions of more complex biotech medications. Lawmakers "should make room for the evolving science," Woodcock said.
Rep. Nathan Deal (R-Ga.) said, "We have an opportunity to provide patients access to a lower-cost alternative for their needed medications," adding, "The status quo is no longer acceptable, and it ignores the possibilities presented by generic biologics." However, Rep. Joe Barton (R-Texas) said that attachment of the bill to legislation to reauthorize the Prescription Drug User Fee Act, as some lawmakers have proposed, would "result in policy that is not fully vetted, and the unintended consequences of our actions in this case could risk lives." Subcommittee Chair Frank Pallone (D-N.J.) said that he has not decided whether to attach the generic biotech medication bill to the reauthorization legislation (CQ HealthBeat, 5/2).
Senate To Consider Bill in June
In related news, Senate Health, Education, Labor and Pensions Committee Chair Edward Kennedy (D-Mass.) on Wednesday said that the committee will mark up the Senate version of the generic biotech medication bill on June 13. Kennedy said that Schumer and Clinton first must reach an agreement with the Senate leadership on the details of the legislation. The final version of the bill likely will include revisions proposed by Kennedy and Sen. Orrin Hatch (R-Utah) (Edney/Johnson, CongressDaily, 5/3).