Improving Drug Safety
Since this article does not have an abstract, we have provided the first 150 words of the full text.
- KEYWORDS:
- DRUG INDUSTRY
- DRUG REACTION, ADVERSE
- NONPRESCRIPTION DRUGS
- PATIENT SAFETY
- PUBLIC HEALTH
- QUALITY CONTROL
- UNITED STATES FOOD AND DRUG ADMINISTRATION
- WORLD HEALTH
Citing a record 1742 drug recalls in 2009, a 400% increase from 2008, Sen Michael Bennet (D, Colo) introduced legislation designed to enhance the ability of the Food and Drug Administration (FDA) and the pharmaceutical industry to ensure that medications are safe and effective regardless of where they are manufactured.
The bill (S 3690 [http://thomas.loc.gov]), introduced August 3, would enhance the FDA's ability to track and monitor foreign manufacturing sites and give the agency additional recall power and enforcement options, such as assessing civil penalties. The bill also requires companies to institute quality management plans to ensure quality and safety of their drugs, plans that would include stronger supplier oversight and document which entities are involved in the manufacturing supply chain for their drugs.
In addition, the bill would give the FDA new oversight of over-the-counter (OTC) drugs and prevent the agency from relegating such drugs to a …
