Congress Working To OK Generic Biotech Drugs
Democratic and Republican congressional leaders "are working feverishly on legislation that could give consumers access to lower-cost copies of biotechnology drugs that now cost tens or hundreds of thousands of dollars a year," the New York Times reports (Pear, New York Times, 4/8).
Companion bills (HR 1038 and S 623) introduced earlier this year by Rep. Henry Waxman (D-Calif.) 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 (American Health Line, 3/7).
Consumer groups, employers and health insurers support the legislation, which they maintain would make biotech medications more affordable and reduce health care costs. According to the Times, generic versions of biotech medications could cost 15% less than brand-name versions and could cost more than 60% less in the event that several rival generic versions reach the market.
Arney Rosenblat, a spokesperson for the National Multiple Sclerosis Society, said, "Many patients are denied access to these important drugs because even the copayments can reach thousands of dollars a year."
However, companies that manufacture brand-name versions of biotech medications "contend that biotechnology products, made from cells and living organisms, are so complex that a copy will never be identical to the original and therefore cannot be certified as safe without testing in humans."
Susan Desmond Hellmann, president for product development at Genentech, said, "Some level of clinical testing should be required in all cases."
Jay Siegel, a senior scientist at Johnson & Johnson, said, "I would never take a biologic that had not been tested in humans. The risks are too high."
However, Janet Woodcock, chief medical officer of FDA, has said that FDA has the ability to determine which trials are necessary to ensure the safety and effectiveness of generic versions of biotech medications.
Sen. Orrin Hatch (R-Utah) said he expects Congress to pass legislation that would allow FDA to approve generic versions of biotech medications later this year (New York Times, 4/8).
Efforts by lawmakers to pass legislation that would allow FDA to approve generic versions of biotech medications "is an attempt to fit a new problem into a framework for which it wasn't designed," a Wall Street Journal editorial states. The "high prices of biologics reflect the difficulty and expertise required to develop these medicines," according to the editorial.
"It should be possible to preserve incentives to innovate while advancing legitimate public health goals like increased access," the editorial states, adding, "And generics can play a useful role in spurring the reformulation of existing medicines in more efficacious ways."
The editorial concludes, "The challenge is to strike a balance between access and innovation, which Mr. Waxman and his allies fail to do. The real costs of this agenda might well be fewer new biological therapies" (Wall Street Journal, 4/10).