Legislation introduced that would give FDA authority to approve generic versions of biotechnology drugs

Feb 19 2007

Lawmakers in the House and Senate on Wednesday introduced a bill that would allow FDA to approve generic versions of biotechnology medications, USA Today reports (Schmit, USA Today, 2/15).

According to the St. Paul Pioneer Press, the Access to Life Saving Medicine Act of 2007 and similar legislation "has long been supported by manufacturers of generic drugs who currently lack a clear regulatory pathway for making lower-cost versions of biopharmaceutical medicines" (Snowbeck, St. Paul Pioneer Press, 2/15). Under the legislation -- sponsored by Rep. Henry Waxman (D-Calif.), Sens. Charles Schumer (D-N.Y.), Hillary Rodham Clinton (D-N.Y.) and others -- FDA could 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. However, the legislation would not require companies that seek to market comparable or interchangeable generic biotech medications to conduct clinical trials. Schumer said he will seek to attach the bill to legislation that would reauthorize the Prescription Drug User Fee Act (Wayne/Perine, CQ Today, 2/14). House Energy and Commerce Health Subcommittee Chair Frank Pallone (D-N.J.) said the committee plans to consider the legislation at a hearing in early spring (Johnson, CongressDaily, 2/14).

Support

Supporters maintain that the bill would reduce the cost of biotech medications, which can cost $5,000 or more monthly, and could save Medicare as much as $14 billion over 10 years. According to supporters, the legislation "appropriately grants the FDA a role in determining when clinical trials would be necessary for a generic biopharmaceutical" (St. Paul Pioneer Press, 2/15). Waxman said, "This bill will give FDA the clear legal authority to approve safe and effective copies of biotech drugs. Introducing fair competition for biotech drugs is essential to keep these life saving treatments affordable." Clinton said, "We should bring safe, effective and affordable generic versions of these medicines to patients. It will save money and save lives" (Cohen, Newark Star-Ledger, 2/15). The Pharmaceutical Care Management Association and the Generic Pharmaceutical Association support the bill (CongressDaily, 2/14). In addition, several companies outside the pharmaceutical industry -- such as General Motors, Ford Motor and DaimlerChrysler -- support the legislation, which they hope will help reduce health care costs (CQ Today, 2/14).

Opposition

However, opponents of the legislation maintain that "true generics aren't possible because biologics come from complicated living organisms" that companies cannot reproduce without "significant changes in final products," USA Today reports (USA Today, 2/15). The Pharmaceutical Research and Manufacturers of America and the Biotechnology Industry Organization, among others, oppose the bill (CongressDaily, 2/14). James Greenwood, president and CEO of the Biotechnology Industry Organization, said, "No matter how many scientific instruments you use to manufacture (a generic), there's going to be a difference between it and the molecule that's been on the market by the originator." Biotechnology company Amgen in a statement said, "Any system for evaluation of follow-on biologics must be scientifically rigorous, including clinical evidence, to ensure patient safety and to maintain patient confidence in the integrity of biotechnology medicines" (CQ Today, 2/14).

Express Scripts Study

Consumers and health insurers could save as much as $71 billion over 10 years in the event that FDA begins to approve generic versions of biotech medications, according to a study released on Thursday by pharmacy benefit manager Express Scripts, the AP/Atlanta Journal-Constitution reports. For the study, Express Scripts reduced by 25% the prices of brand-name biotech medications in four classes that currently would have generic competition because of expired patents. The four classes of biotech medications were insulin for diabetes, erythropoietins for anemia and growth hormones and treatments for multiple sclerosis. The study found that on average biotech medications cost $71,600 annually, compared with $1,200 for standard treatments. In addition, the study found that biotech medication costs likely will more than double to $90 billion in 2009, "a rate three times faster than traditional drugs," the AP/Atlanta Journal-Constitution reports. Biotech medications currently account for 25% to 30% of prescription drug costs for companies, according to the study (Agovino, AP/Atlanta Journal-Constitution, 2/15). Steve Miller, chief medical officer of Express Scripts, said, "The dollars to be saved are really big -- and probably even bigger than what we've put into this study." Miller added, "There would be lots of companies ready to jump into the fray and make these products" because of their revenue potential (Melcer, St. Louis Post-Dispatch, 2/15).