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FDA Expands Control Over Compounding Pharmacies

In previous posts, we have discussed the dangerous nature of compounding pharmacies, including the lack of federal regulation, the risk of counterfeit, and the general threat to consumers in Massachusetts and nationwide. Last year a meningitis outbreak and other events involving compounded drugs lead to serious infection and in many cases resulted in death. Since the outbreak, Congress has been working to pass comprehensive legislation to give authority to the FDA to properly regulate compounded drugs. According to an official statement from the FDA, a new law may help to properly regulate the industry and keep consumers safe.

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The risk of dangerous or defective drugs produced by compounding pharmacies is significant. Our Boston injury attorneys are dedicated to protecting the rights of individual clients as well as consumers nationwide. We will take necessary action against compounding pharmacies and are committed to staying abreast of legal developments that may have a positive impact on the health of our nation. The Drug Quality and Security Act is a positive step in this direction.

The FDA has finally taken action after the meningitis outbreak which was traced to epidural steroid injections packaged and marketed by the New England Compounding Center in Framingham. There were steroid injection doses distributed throughout 23 states and administered to over 14,000 patients in August of 2012. Infections spanned 19 states and by March of 2013, 48 people died and there were 720 requiring treatment for the infections. Many patients who suffered from meningitis also experienced secondary infections.

In late 2012, members of Congress blamed the FDA for failing to prevent the crisis failing to act against the Massachusetts compounding pharmacy (Congress, had failed to do just that by rejecting a measure sponsored by the late Ted Kennedy, which would have regulated the industry). Currently, there are over 400 lawsuits against the NECC. This year, Massachusetts has shut down two more pharmacies because of sterility concerns that were discovered after an inspection. The Congressional move could signal a step in the right direction to ensure that compounding pharmacies are properly regulated.

According to critics, the problem is that the drug supply chains were not properly regulated to protect consumers from contaminated, counterfeit, stolen, and other dangerous drugs. The Drug Quality and Security Act allows the FDA to protect public health by giving the FDA oversight of entities that prepare compounded drugs. Facilities must register with the FDA to be able to package and outsource drugs. This means that they will be required to follow federal quality standards.

In addition to registering with the FDA, compounding facilities will also be subject to FDA inspections. Any outsourcing entities, including hospitals and other providers can provide patients with compounding drug facility products, but only upon registration. According to the FDA, this means that the new system will encourage providers to ensure that products are registered with the FDA and subject to inspections. The FDA asserts that the state boards will continue to have primary responsibility for the oversight of pharmacy compounding. The FDA also hopes to create a tracing system to identify the source of compounded drugs.

While registration and inspections may increase the likelihood of safety in the future, many victims and their families are still suffering from the meningitis outbreak. If you or someone you love was injured, you may be entitled to compensation.

If you are the victim of a defective medical device in Massachusetts, call the Law Offices of Jeffrey S. Glassman for a free and confidential appointment — 1-888-367-2900.

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