Greater Access to Generic Drugs : Part 2

by Food and Drug Administration (FDA)

(Page 2 of 3)

Reducing Legal Barriers

The Medicare Modernization Act will close legal loopholes in the Hatch-Waxman Act that delay generic drug approval. For example, only one 30-month "stay" is allowed under the Act if an innovator company sues a generic company over patent issues. This may occur after a generic applicant certifies that an innovator's patent will not be infringed. Unless the innovator sues within 45 days after such notice, there is no 30-month stay. The innovator can still sue, but no 30-month stay results.

A stay is the term for the delay in generic approval that occurs when a brand-name company files a patent infringement lawsuit. This delay is meant to be a time to resolve issues about whether a generic drug company is infringing a drug patent. During the stay the FDA cannot approve the generic drug.

A limit of one 30-month stay is in line with recommendations from the Federal Trade Commission (FTC). According to an FTC study released July 30, 2002, there were cases involving several brand-name drugs between 1994 and 2000 in which repeated 30-month stays delayed access to generic drugs.

Access to generic drugs has sometimes been delayed from four to 44 months when drug companies have used various methods to get repeated 30-month stays. Examples of delaying tactics include submitting patent information on the color of the pill bottle, ingredient combinations, and other minor matters that don't affect the drug's effectiveness or safety.

Such strategies have been seen only in a minority of drug firms. And, according to PhRMA, stays are rare. But the FTC concluded that multiple stays can have substantial financial impact and are "harmful to consumers." President Bush has said, "Our message to brand-name manufacturers is clear: You deserve the fair rewards of your research and development; you do not have the right to keep generic drugs off the market for frivolous reasons."

A new regulation that went into effect Aug. 18, 2003, implements another FTC recommendation, to tighten the patent submission and listing process so that only appropriate patents are submitted to the FDA. To help prevent unfair competition, the regulation clarifies the types of patents that must be submitted to the FDA. Companies must submit patent information on active ingredients, drug formulations and compositions, and approved uses of a drug. Certain patents, such as those for packaging claims, are among those that cannot be submitted. More detailed information will now be required on patent submissions, and false statements could lead to criminal charges.

Kathleen Jaeger, GPhA president and chief executive officer, praised the announcement of the generic drug regulation and said it complements generic drug access provisions of the Medicare Modernization Act.

"GPhA strongly believes that the administration's initiatives, coupled with substantial legislative measures in the compromise legislation, will ensure that American health care becomes more affordable," Jaeger said in a statement. The legislation overlaps with the FDA's regulation in one area in that it would also prevent multiple 30-month stays in the approval of generic drugs.

In testimony before the Senate Judiciary Committee on June 17, 2003, Bruce N. Kuhlik, PhRMA's senior vice president and general counsel, cautioned against changes that could "undermine incentives for continued pharmaceutical innovation." He said, "The Hatch-Waxman Act of 1984 is achieving its purpose of speeding market entry of generic drugs."

Kuhlik pointed out that since the law was enacted, the generic share of the drug market has soared, and so has the expense of developing new drugs. "Our patent laws and regulations provide a key incentive for continued innovation in medicines," Kuhlik said. "Better treatments and new cures can come only from pharmaceutical research companies, and only if patent incentives are maintained."

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.