Hatch is pushing medication bill

WASHINGTON -- Dietary supplement and over-the-counter medications would have a new mandatory reporting system for any illnesses, death or other problems associated with their products, based on a bill introduced Wednesday by Sen. Orrin Hatch, R-Utah, and Sen. Dick Durbin, D-Ill.

The new bill builds on the Dietary Supplement Health and Education Act that Hatch sponsored and Congress supported in 1994. Right now, the Food and Drug Administration regulates these two types of products, but there is only a voluntary system for companies to report any problems.

Under the bill, manufacturers, packers or distributors of over- the-counter drugs or dietary supplements would need to file a report to the FDA within 15 days of any reported incident of an adverse health effect specified in the bill such as death, inpatient hospitalization, birth defects and several others. They would also have to keep records for six years of any reported health problem, even if it is not under a "serious" one listed in the legislation.

"This is an important public health initiative, which at the same time safeguards access to dietary supplements and over-the-counter drugs," Hatch said.

The Utah Natural Products Association, National Nutritional Foods Association, the Center for Science in the Public Interest and the Council for Responsible Nutrition all support the bill.

Durbin said the "strange bedfellows" coming together to support the legislation -- he and Hatch do not always see eye to eye -- demonstrates the quality of the bill.

"Those who are selling dangerous products will have to face the music," Durbin said.

Sen. Tom Harkin, D-Iowa, also a co-sponsor of the bill, said that filing a report is not evidence of anything and does not automatically mean a product is unsafe but it could lead the government to discover where there might be a problem. Harkin said if this was in place problems associated with ephedra would not have happened.

"This is another example of how good legislation can come out of a serious situation," Harkin said.

The Senate Health, Education, Labor and Pensions Committee will take up the bill next week, and Hatch hopes it will be passed this year. There is no identical bill in the House yet.

Hatch did not know an exact cost of the reporting procedures and other protocol laid out in the bill but estimates say about $2 million for over-the-counter-drugs and $2 million for supplements.