Senate Bill Would Bolster Drug Safety Requirements

The nation’s current drastic increase of pharmaceutical recalls has resulted in a new bill being put into action by the Senate, one that will allow the Food and Drug Administration (FDA) to have more control over drug companies and the drugs they are manufacturing.

While the FDA has some power concerning the drugs that are being sold, many recalls have seemed to slip through. The agency simply lacks authority where pharmaceutical companies are concerned. The new bill will provide the FDA with the funds needed to adequately protect the people, and it will ensure that all drugs that are being manufactured globally pass all safety inspections before being marketed in the United States.

Will the Bill Pass?

The Hill political publication reports that a poll showed 89 percent of Americans will support the bill and congressional action to increase the nation’s drug safety protections. The poll also indicated that 58 percent of consumers said that they “strongly support” this action.

However, those working for pharmaceutical companies say they are not sure if the bill will pass or not. They claim that firmer rules and regulations are not necessary, and that the United States has one of the best and safest systems in the world for testing drugs and protecting patient and consumer safety. That argument seems to fail when we look at Europe’s history of taking dangerous drugs off the market well before the FDA, as happened in the recent Meridia recall.

About the New System

The new bill would update the FDA’s data systems in order to locate all global manufacturers that provide America with drugs. It would also force these companies to document every source that contributes to their products. This will ensure that, in the event of a recall or defective product, all locations and parties involved will be readily available to contact. The bill will also grant the FDA subpoena authority when the need arises to conduct investigations. The FDA enforcement of drug safety has been hindered by underfunding as well as legal restrictions, limitations that the bill would eliminate.

Most importantly, FDA officials only have authority to recall drugs in the medical industry. They do not have such power over pharmaceutical drugs. This bill would allow the FDA to recall drugs prescribed at pharmacies and given to patients in hospitals.

Statistics

According to The Hill, “Last year…the country saw a record 1,742 drug recalls…a 400 percent jump over 2008….80 percent of the active ingredients in the nation’s pharmaceuticals are made abroad, where safety regulations are often much less stringent than U.S. guidelines.” While this outsourcing to other countries is designed to benefit shareholders, oftentimes the quality of the product may be sacrificed in order to cut the cost of making the drug.

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