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Clark Love & Hutson

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The Nationally Recognized Plaintiffs Litigation Law Firm

FDA creates new drug quality office

On Behalf of | Mar 15, 2018 | Uncategorized |

Houston residents who take medication know how important it is for their health. Medication is necessary for many people and can help with ongoing health concerns or short term situations. Usually the medication is safe and effective, but occasionally there are serious complications. Complications can lead to unexpected injuries and even death. Recently, the Food and Drug Administration announced that it is creating a new drug quality office.

The new Office of Pharmaceutical Quality of the FDA will be established to “make its focus on manufacturing more systematic.” Recent occurrences of drugs that were recalled because of manufacturing errors has made many consumers wary of the origins of the drugs they are taking. The popular heart drug metoprolol, for example, was recalled because it wasn’t dissolving properly. Additionally, in 2012 the FDA also concluded that a generic extended release version of Wellbutrin was not the same as the non-generic version.

The FDA has said that this new office will help bring equality to the generic and non-generic version of drugs. It will also integrate the quality process by the FDA and streamline the reviews needed for approval of drugs and inspections of manufacturing facilities. Although the FDA doesn’t explicitly mention the recent drug recalls it is hoped that this new office will reduce those numbers and make sure the quality of all drugs is high.

Pharmaceutical companies have a duty to manufacture safe and effective drugs. When there is a breakdown in the process of manufacturing these drugs in a safe way consumers can face unexpected injuries.