NACDS claims victory on pivotal FDA bill provisions

ALEXANDRIA, Va. Today, the National Association of Chain Drug Stores applauded congressional negotiators for approving an FDA reform bill free of several dangerous provisions that were contained in earlier versions of the bill. U.S. House of Representatives and Senate negotiators reached a compromise on the legislation, and the two chambers passed H.R. 3580, The Food and Drug Administration Amendments Act of 2007.

NACDS hailed the removal of Senate passed provisions that would have mandated onerous and costly prescription drug pedigree requirements, mired chain drug store internet sites in additional federal regulations and allowed for importation of dangerous prescription medicine from overseas. In addition, the bill contains highly favorable changes that will help speed generic drugs to the marketplace.

“This victory is a result of persistence, credible arguments, strong member involvement and a Congress that listened,” said Steve Anderson, NACDS president and chief executive officer. “On behalf of community pharmacy and patients across the country, we averted substantial problems in the bill, and achieved progress on sound policies.”

NACDS applauds the removal of provisions in the bill that would have required costly, complicated and unnecessary systems for tracking and tracing prescription drugs with unrealistic timeframes. NACDS’ push to strike these provisions prevailed. The Association supports and looks forward to working with the Department of Health and Human Services on the development of standards for tracking and tracing prescription drugs.

NACDS applauds changes made by Congress in reforming the citizen petition process, which has been used to delay market entry of generic drugs. These changes should improve competition in the prescription drug marketplace and reduce costs for patients, employers, and the government.

Negotiators removed provisions from the bill that would have added regulations to legitimate internet sites operated by state-licensed retail pharmacies. The provisions originally were included with the intention of diminishing “rogue” internet sites. While these sites have been a great concern for NACDS and its members due to their threat to patient safety, proposing more regulations to legitimate pharmacies would have been duplicative and burdensome. NACDS has worked with Congress to eliminate illegal internet sites from the market, but not at a detriment to legitimate internet sites operated by state-licensed retail pharmacies.

Another point of success comes from a provision on importation, which was removed from the original bill. NACDS recommended striking the provision that allowed importation (both personal and commercial) from multiple countries due to safety and cost effectiveness.

The legislation must now be signed by President Bush to become law.