Live Chat
Call Now: (312) 600-0000
Get a FREE Case Review
Leading Lawyers logo
Super Lawyers logo
American Association for Justice
WILG logo
Illinois Trial Lawyers Association logo
Avvo Rating logo
Workers' Compensation Lawyers Association logo

Meningitis Outbreak Prompts FDA to Urge Congress to Increase Regulation of Compounding Pharmacies

Written by Ankin Law Office

Compounding pharmacies play a critical role in the pharmaceutical and health care industries. Unlike drug manufacturers, which create medications, compounding pharmacies use a licensed pharmacist to combine, mix, or alter drug ingredients to create a medication tailored to the medical needs of an individual patient. If done properly, pharmaceutical compounding can serve an incredibly useful function in the administration of health care by treating those patients who cannot be treated with an FDA-approved medication.

But compounding pharmacies can also cause massive health problems if they do not use the appropriate techniques or take the necessary precautions when mixing the drugs. To date, hundreds of people have become ill and at least 53 people have died as a result of contaminated steroid shots that were produced by a compounding pharmacy. Michigan and Tennessee have been the hardest hit by the meningitis outbreak, with Indiana as the third hardest hit state, reporting 85 illnesses and 11 deaths.

The pharmacy linked to the meningitis outbreak – New England Compounding Company (NECC) – and its employees are currently the subject of several criminal and civil investigations, and the NECC filed for Chapter 11 bankruptcy court protection in order to establish a fund to compensate those who were affected by the meningitis outbreak.

Last fall federal lawmakers held Congressional hearings regarding oversight of drug compounding practices. During those hearings, Dr. Margaret A. Hamburg, the head of the FDA, testified that additional oversight authority over compounding pharmacies is required in order to prevent future contaminations and tainted drug problems, reported the Washington Post. Dr. Hamburg recently renewed her request for additional legislation to regulate compounding pharmacies on the FDA’s blog last month.

In the post, she wrote:

“While our investigation of this deadly outbreak has been a top priority, our responsibility at FDA is also to help make sure this doesn’t happen again. We are currently deploying resources to work with states to inspect certain state-licensed pharmacies that produce sterile drug products that we believe may present the highest risk… But our authorities are limited and not the right fit for FDA to provide appropriate and efficient oversight of this growing industry. There should be legislation that establishes appropriate, minimum federal standards for firms that compound sterile drug products in advance of or without a prescription and ship them interstate.  FDA must have clear authority to proactively inspect pharmacies to determine the scope and nature of their operations.”

The Chicago unsafe pharmaceutical attorneys at Ankin Law Offices, LLC are committed to protecting the public from dangerous pharmaceuticals. If you have been injured by the meningitis outbreak or another unsafe pharmaceutical, contact the skilled Chicago unsafe pharmaceutical drug law firm of Ankin Law Offices, LLC at (312) 600-0000 to discuss a possible personal injury or product liability lawsuit.

Categories: Product Liability