Senate Health, Education, Labor and Pensions Committee Chair Edward Kennedy (D-Mass.) and Sens. Hillary Rodham Clinton (D-N.Y.), Mike Enzi (R-Wyo.) and Orrin Hatch (R-Utah) on Friday announced an agreement on legislation that would allow FDA to approve generic versions of biotechnology drugs, CongressDaily reports (CongressDaily, 6/25). Supporters of the bill are expected to try to add the measure to legislation that would reauthorize the Prescription Drug User Fee Act. According to a summary of the agreement, FDA would be authorized to approve generic biotech drugs 12 years after agency approval of the original product (Reichard, CQ HealthBeat, 6/22).
The agreement would guarantee four years of exclusive sales for brand-name biotech drugs before a generic manufacturer could submit an application to FDA. Generic applications would be required to include at least one clinical study, but FDA would have the authority to waive that requirement (Wilde Mathews, Wall Street Journal, 6/23).
The agreement summary stated that FDA would be able to approve generic biotech drugs "as interchangeable, meaning it can be substituted for the brand product without the intervention of the health care provider who prescribed it." For approval as an interchangeable drug, evidence must be provided showing that the product "will produce the same clinical result as the brand product in any given patient and that it presents no additional risk in terms of safety or diminished efficacy if a patient alternates or is switched between products," according to the summary. The first interchangeable product approved by FDA would have one year of market exclusivity under the bill.
CQ HealthBeat reports that the agreement is a "breakthrough because it unites key players who had been at odds over the terms" of allowing FDA to approve generic biotech drugs. However, "[o]bstacles to passage remain ... particularly if the biotech industry decides to try to derail the measure," according to CQ HealthBeat (CQ HealthBeat, 6/22).
Kennedy's committee on Wednesday is expected to mark up the proposal (CongressDaily, 6/25). The Senate already has approved user fee legislation (S 1082), while the House Energy and Commerce Committee on Thursday unanimously approved its version of the bill (CQ HealthBeat, 6/22). The Wall Street Journal reports that it is "unclear" whether any Senate language on generic biotech drugs "would survive a House and Senate conference" (Wall Street Journal, 6/23).
Hatch in a press release announcing the agreement said, "It's taken a lot of effort, but we've reached good balance with this bill. Just as we did with [the 1984 Hatch-Waxman Act, which was meant to accelerate the market entry of generic drugs,] we're giving incentives for both pioneer and generic drug firms." Enzi said that "very shortly, Senators Kennedy, Hatch, Clinton and I will look back at this legislation with great pride, as it will be seen as a vital part of insuring our aging population has access to innovative, reliable and safe medicines."
Spokespersons for the Biotechnology Industry Organization, the Generic Pharmaceutical Association and AARP said they needed more time to examine the agreement before commenting (CQ HealthBeat, 6/22).
Editorial, Opinion Piece
- Boston Herald: The Massachusetts biotech industry "worries that the FDA approval process some have proposed for these generic medications might bring unsafe drugs to market -- and eliminate the financial incentive for local biotech companies to develop new treatments," a Herald editorial states. "In determining what" the process for approving generic biotech drugs "will ultimately be, the Senate must act both to protect patient safety -- and an industry vital to this state's economy," the editorial concludes (Boston Herald, 6/25).
- James Bianco, Boston Globe: "Congress can and should develop a pathway for approval of follow-on biologics" that "require[s] manufacturers to perform essential clinical trials, though not the full phase I-II-III trials for new biologics," Bianco, president and CEO of Seattle-based Cell Therapeutics, writes in a Globe opinion piece. Bianco adds that during the last several years, "technological and scientific advances have shown that biological products can be brought to market more efficiently while maintaining the highest standards for safety and effectiveness" (Bianco, Boston Globe, 6/22).
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Publication Date: 2007-06-27 04:00