| SUBJECT |
President George W. Bush has announced a rule that he says would improve access to generic drugs and consequently lower prescription drug costs. The rule closes loopholes in the implementation of the 1984 Hatch-Waxman drug patent law. Under Hatch-Waxman, a generic drug cannot be marketed if the brand-name manufacturer files a new patent on a drug it is already selling. Often the new patents are considered frivolous, concerning, for example, the color of the pill bottle. However, the tactic buys the brand-name company an automatic 30-month stay in the approval of an equivalent generic drug (C&EN, Sept. 23, page 53). By filing multiple new patents, the brand-name manufacturer can trigger several successive delays. According to a recent Federal Trade Commission study, marketing of eight generic drugs has been delayed in this way since 1992 (C&EN, Aug. 5, page 11). Bush's new plan will allow only one automatic stay in a drug's approval. He estimates the rule will save $3 billion a year in the nation's prescription drug costs. The Generic Pharmaceutical Association welcomes the President's "commitment to remove barriers to generic competition." However, the proposed rule covers only about 60 to 70% of the issues addressed by a Senate-passed bill, S. 812, an association spokesman says. "Legislation is still needed to codify and strengthen the proposed rule," he says, but he doesn't expect the House to pass a similar bill this year, in part because the White House is opposed to S. 812. Pharmaceutical Research & Manufacturers of America, which represents the brand-name drugmakers, calls Bush's proposal a "very major development." |
| UPDATE | 10.02 |
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