Adverse events bill awaits Bush's signature
Non-Prescription Drug Consumer Protection Act on adverse events
reporting, and the bill is now on its way to President George W
Bush for signature.
The bill, which first passed the Senate by unanimous consent last Wednesday, is designed to amend the federal Food, Drug and over-the-counter drugs to the United States Food and Drug Administration (FDA).
Preparations for adopting the prospective new rules of practice are already underway in the industry as the bill is on its way to President Bush, who could exercise his authority to veto the legislative change.
"We'll encourage the president to sign it into law," Natural Products Association (NPA) executive director and CEO, David Seckman, told NutraIngredients-USA.com.
Thepassage of the bill represents a success for dietary supplement trade associations, and not only becuase it is the result of months of lobbying; it was the last action voted on by the 109th Congress - coming through just minutes before the House adjourned.
The bill was placed on the suspension calendar, meaning it required a two-thirds majority to pass. The result was 203 in favor, 98 against. The opposition consisted of 94 Republicans and four Democrats.
The industry must now wait for the bill to become an enrolled bill. This means this paper has to be signed by appropriate House and Senate officials, and submitted to the President for signature to become law.
"You never can tell how long it will take," said Seckman.
Industry associations have advocated the bill as an extra post-market precautionary measure. It requires supplement labels to include a telephone number for the reporting of serious advert events, and requires supplement companies to pass on these reports to FDA within 15 days.
"We have long said passing the legislation is the responsible, right thing to do for both the industry and consumers," said Seckman.
The bill has been promoted by the industry as a means of securing more credibility for its products by shielding them from critics who say dietary supplements are ineffectively regulated.
"An industry system that puts consumers first will increase consumer confidence and will accrue the corresponding benefits," said Seckman.
Existing legislation has drawn criticism because it does not require the same pre-market approval for supplements as for prescription drugs. The dietary supplements industry is regulated by DSHEA, the 1994 Dietary Supplements Health and Education Act. This bill would represent the first amendment to DSHEA.
In June, the proposed amendment was introduced in Congress as a bipartisan bill. Republican senator Orrin Hatch from Utah and Democrat senator Tom Harkin from Iowa were behind the bill.
Bringing the legislation to where it now stands has occurred in part due to the legwork of industry members and supporters. In recent months, trade associations were active in getting constituents to contact their representatives.
"We initiated a grassroots campaign," said Seckman. "We think that it had some pretty positive results."
NPA further stepped-up its advocacy efforts after the bill cleared the House of Representatives. The association had urged members to call and email their representatives up until Friday night, and the bill was passed in Congress the following day.
"When a bill is brought up at the last minute like this, there's a lot of activity," said Seckman. "It helps if representatives hear from their constituents."
Industry associations are now faced with the task of educating industry as to how to adopt AERs in their manufacturing and distribution practices.
The American Herbal Products Association, for instance, has scheduled a seminar program on AERs in January in Utah.
Seckman said NPA will also be contacting the new representatives when Congress convenes to educate them about the bill.
