Release date: 6/21/2006
NORTHRIDGE, Calif. (June 21, 2006) — Pharmavite LLC, maker of Nature Made vitamins, today applauded Senate introduction of bipartisan legislation that would require dietary supplements and over-the-counter drug manufacturers to report any reports they receive of serious adverse events to the Food and Drug Administration (FDA). Bill S. 3546, "Dietary Supplement and Nonprescription Drug Consumer Protection Act," was introduced today by U.S. Senators Orrin Hatch (R-UT), Tom Harkin (D-IA) and Richard Durbin (D-IL) at a press conference in Washington.
Pharmavite has long advocated federal serious adverse event reporting. The company began voluntarily reporting such events to the FDA in 2004.
“We commend Senators Hatch, Harkin and Durbin for their leadership introducing this important bipartisan consumer protection legislation,” said Paul Bolar, vice president, regulatory affairs, Pharmavite. “As a responsible manufacturer committed to consumer safety, we urge the U.S. Senate to quickly pass this bill and are hopeful the U.S. House of Representatives will do the same.”
The bill will:
• Mandate serious adverse event reporting by over-the-counter product and supplement manufacturers to FDA within 15 business days of receipt;
• Require companies to maintain all adverse events reports received for 6 years;
• Make knowingly submitting false reports a punishable offense.
Adverse event reporting does not associate a cause to the adverse event, but does let the FDA know that an event occurred. Federal legislation will pre-empt state and local laws, and provide clear, understandable guidelines to consumers, health care professionals and manufacturers. The reporting mandate becomes effective one year after the date of enactment of the bill. The bill is expected to be reviewed in the Health, Education, Labor and Pensions (HELP) committee by the end of June.
The legislation is one of a number of steps toward responsible dietary supplement regulation advocated by Pharmavite. Bolar states, "We also hope that the Office of Management and Budget will publish final good manufacturing practices regulations for supplements. These have been stalled for over a decade. Finally, we believe that the FDA's budget to enforce quality and safety standards provided for under the Dietary Supplement Health and Education Act needs to be increased. We continue to call upon Congress and the Administration to allocate sufficient funds for this oversight.”
About Pharmavite
For more than 30 years, Pharmavite has earned and maintained the trust of pharmacists, consumers, and retailers by manufacturing high-quality vitamins, minerals, herbs and other dietary supplements that are safe, effective and science-based. As an industry leader, Pharmavite adheres to manufacturing standards recommended by the United States Pharmacopeia (USP), a not-for-profit organization that has set pharmaceutical and dietary supplement quality standards since 1820. In addition, Pharmavite participates in USP’s Verification Program for dietary supplements.
The dietary supplement industry is regulated by the U.S. Food and Drug Administration and the Federal Trade Commission, as well as by government agencies in each of the 50 states.
