US NAPM Slams "Pediatric Research" Patent Extensions Plans

During the last weekend that the US Congress was in session, legislation surfaced to provide an additional six-month period of exclusivity for drugs for which companies performed pediatric research, either during the drug's development or after Food and Drug Administration approval.

The National Association of Pharmaceutical Manufacturers (which represents the non-research based pharmaceutical industry) has sent letters to Senators Nancy Kassebaum and Edward Kennedy noting that the legislation - introduced without a Congressional hearing, a budget estimate of its impact on taxpayer dollars or a review of proposed legislative language - would have lowered standards for pediatric research, provided incentives only for brand-name companies, excluded incentives for pediatric research for biologicals or medical devices, and would have cost the consumers and taxpayers well over $1 billion in increased health care costs. The NAPM also contacted the staffs of Senators Daschle, Pryor and Kerrey, the Senate Committee on Labor and Human Resources, the Senate Select Committee on Aging, the House Commerce Committee and the Senate and House Budget Committees. The legislation never went anywhere.

Congress was also praised by the NAPM for its rejection of lobbying efforts to protect brand-name drugs from generic competition. NAPM vice chairman Thomas Russillo said that the pressure for patent extension and/or additional market exclusivity periods would have added billions of dollars to consumers' and taxpayers' costs. Top praise went to Sen Pryor, who Mr Russillo said took a leadership role in protecting access to generics. The specific legislative proposals defeated included: