- The Washington Times - Wednesday, December 13, 2006

Manufacturers of over-the-counter drugs and dietary supplements would be required to notify the federal government of serious adverse reactions to their products as a result of legislation passed last week.

Beginning next year around this time, manufacturers and distributors of the products — including such medicines and supplements as aspirin, ibuprofen, cold medicine, ginseng, vitamins and creatine — must report to the Food and Drug Administration any adverse-reaction cases associated with their products. The legislation is expected to be signed by President Bush.

“This law will do a lot in terms of consumer confidence surrounding the dietary supplement industry,” said Steve Mister, president of the Council for Responsible Nutrition, a leading industry trade association, which represents companies such as NBTY Inc. and Pharmavite LLC.

The legislation would require companies to provide phone numbers on the products for consumers to call to report the reaction; the business would have 15 days after that to contact the FDA. Examples of reportable events include hospitalization, birth defects, disability or incapacity and surgical intervention.

About 125 million Americans are taking some type of dietary supplement and spend more than $20 billion a year for dietary supplements, which include vitamins, minerals, herbs and botanicals, and sports nutrition supplements, according to the Nutrition Business Journal, a research and consulting firm.

Over-the-counter drugs such as ibuprofen and Tylenol also would have to comply with the new law. Over-the-counter drugs that have been on the market for years, such as aspirin, have not been forced to report adverse events unlike new nonprescription drugs, such as Claritin.

“The law will not only bolster public confidence and but will standardize the scope and extent of reporting to the FDA,” said Elizabeth Assey, director of communication for the Consumer Healthcare Products Association, the leading trade association for over-the-counter drug manufacturers.

The legislation protects the manufacturers from lawsuits stemming from the adverse-reaction reports.

“There are important protections in the law against lawsuits. They are the same protections pharmaceutical companies get when they report an adverse event,” said Tony Young, general counsel to the American Herbal Products Association.

In the last vote of the 109th Congress in the early-morning hours of Saturday, the House gave final approval to the legislation authored by Utah Republicans Sen. Orrin G. Hatch and Rep. Chris Cannon. Sen. Richard J. Durbin, Illinois Democrat, also pushed for the bill.

The supplement drug industry is largely behind the effort to more closely regulate its products. The industry says alerting federal health inspectors to adverse events is responsible and will help improve the companies’ images.

“We see this as the ethically right thing to do,” said Michael McGuffin, president of the American Herbal Products Association. “And there is an image factor. Our critics will no longer be able to say our products aren’t safe.”

Reporting the problems means the FDA would be able to identify patterns leading to the source of a problem, such as tracing it back to a common supplier. Such patterns might not be immediately evident to manufacturers dealing with isolated or few incidences.

However, Dr. Stephen DeFelice, founder of the Innovation for Medicine, a nonprofit foundation that promotes the development of dietary supplements, expects the new law to trigger an overflow of reports of adverse events that the agency will be unable to resolve.

“There are so many people taking these supplements today that this law is going to cause more chaos and confusion than resolution,” Dr. DeFelice said.

The industry attracted congressional scrutiny in the late 1990s, when the energy supplement ephedra, manufactured by Metabolife, was implicated in the 2003 death of Baltimore Orioles pitcher Steve Bechler. Ephedra was banned a year later by the FDA after being linked to heart attacks and strokes.

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