Under the Dietary Supplement and Non-Prescription Drug Consumer Protection Act, any severe adverse reaction -- including hospitalization, incapacitation or death resulting from overdose, abuse or failure of the drug to perform as expected -- reported to the manufacturer in connection with a person using nutritional supplements or over-the-counter medicines must be passed on to the Secretary of Health and Human Services within 15 days.
Currently, doctors, hospitals and other health care providers are required by law to report a severe adverse reaction to a drug or medical device to the FDA through the Medwatch program. Supporters of the bill within the supplement community claim that consumers and health care providers already voluntarily report adverse reactions to dietary supplements to the FDA through Medwatch and the Center for Food Safety and Applied Nutrition Adverse Event Reporting system. Supplement makers have also been reporting adverse reactions of their products for a long time. This bill, they claim, is an opportunity to show how much smaller the supplement-related number of adverse reactions is compared to drugs, and bring down dishonest supplement makers at the same time.
“We have long said passing this legislation is the responsible, right thing to do for both the industry and consumers,” said Natural Products Association Executive Director and CEO David Seckman on the association web site.
However, if President Bush signs the bill, opponents say it will subject nutritional supplements to closer scrutiny than their more dangerous prescription drug counterparts. While it will mean both medical caregivers and supplement manufacturers will have to report major adverse reactions, health advocate Mike Adams said it also meant supplement manufacturers would have to list a 1-800 number on their products for consumers and field a variety of calls, and then pass those reports on to the FDA; a demand not made of drug manufacturers.
"It is a clever scheme of misdirection that will harm the nutritional supplements industry even while claiming to protect it," Adams said, adding that an adverse reaction caused by prescription medication could (and probably would) be blamed on any nutritional supplements the patient was taking. "It's a way for drug companies -- which now have ownership in many of the larger vitamin companies -- to squeeze out the little guys and extend their medical monopoly to the supplements industry," Adams said.
The Senate form of the bill was originally proposed in June by Sens. Orrin Hatch ,R-Utah; Tom Harkin, D-Iowa; and Richard Durbin, D-Ill. and passed on Dec. 6. "Fight for Your Health" author Byron Richards pointed out in an email that the bill was approved by voice vote, without debate or testimony. According to Richards' email, Durbin and Hatch receive large sums of money from law firms that defend Big Pharma clients and Big Pharma itself respectively.
"This is government paid for by Big Pharma and entirely opposed to the will of the people," Richards said.