The Hatch-Waxman Act and New Legislation to Close Its Loopholes

Drug Price Competition and Patent Term Restoration Act of 1984. Status, Abstract and Summary from the Thomas database.

S.1225 - Greater Access to Affordable Pharmaceuticals Act (Introduced in Senate).

The Drug Price Competition and Patent Term Restoration Act of 1984, usually refered to as the Hatch-Waxman Act, was designed to promote generics while leaving in tact a financial incentive for research and development. It allows generics to win FDA marketting approval by submitting bioequivelence studies (as opposed to clinical data, which is costlier to compile). It also grants a period of additional marketing exclusivity to make up for the time a patented pipeline drug remains in development. This extension cannot exceed five years, and it is in addition to the 20 years exclusivity granted by the issuance of a patent. Another provision of the Hatch-Waxman grants a 30-month stay to drug companies that file suit against generic manufactures that challenge their patents. This has become controversial in recent years, as pharmaceutical companies have used the provision to keep generics off the market by protecting their drugs with extra patents of poor quality, filing lawsuits to protect the patents even when the lawsuit will be lost, but getting the extra market exclusivity anyway.

Last year, two bills sought to close loopholes in the law exploited by companies to keep generics off the market. The first was S. 812, introduced on May 1, 2002 by Senators. McCain and Schumer and passed on July 31. The House version of the legislation, H.R. 1862, was introduced by Sherrod Brown on May 16, but stalled in the House. On October 21, President Bush announced his intention to use regulatory authority to limit companies to one 30-month extention, and to tighten rules on what patents can be listed in the FDA's Orange Book.

This year, Senators Gregg, Schumer, McCain and Kennedy have introduced similar legislation -S. 1225 - in the Senate.

Statements About and Studies of the Hatch-Waxman Act.

June 2003 - Two Reform Plans for the Hatch Waxman Act
President Bush's Announcement on Limiting 30-Month Extentions
H.R.1862/S.812 - Greater Access to Affordable Pharmaceuticals Act

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