Drug Manufacturers Consent to Oversight by Federal Agency Following Increased Scrutiny

Following a meningitis outbreak that was linked to a faulty drug, several custom drug manufacturers have recently consented to voluntary oversight by the FDA. According to a report by AZ Central, the manufacturers of custom drugs exist in a bit of a legal loophole. These manufacturers often create specific drug “cocktails” designed to treat very specific conditions.

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These “shadow” drug makers, as the article refers to them, came under scrutiny after an outbreak of meningitis was linked to 64 deaths and over 700 illnesses. Under current law, these manufacturers are not regulated by the federal government. However, in 2012, there were two citations issued for unsanitary conditions and a faulty injection.

These specialty drugs, which are prescribed by doctors and filled at regular pharmacies like CVS or Walgreens, are often combinations of other approved drugs. However, since the manufactures operated somewhere between the smaller state-regulated compounding manufacturers and the large-scale drug manufacturers regulated by the FDA, it is unclear who is in charge of making sure these facilities are up to par with the governing safety standards in place.

The FDA estimated that there are roughly 700 of these types of manufacturers across the country. However, only a few have registered with the FDA as of May 16, 2014. Therefore, the FDA recently has pushed voluntary registration for these manufacturers as well as increased scrutiny for those who fail to register. For instance, the two labs that were cited were a part of the FDA’s push to ensure safe facilities and safe drugs.

Medication Errors Can Have Dangerous Consequences

When dealing with any kind of prescribed medication, the consequences of an error can be deadly. For example, the meningitis outbreak mentioned in the article cited above killed over 60 people and made another 700 sick. These types of errors occur when manufacturers are not subject to regulation.

A lack of regulation on the part of the state or federal government means that drug manufacturers can take shortcuts, sacrificing safety, consistency, and efficacy. When these shortcuts are taken, the consumer is the one who suffers.

Liability for Medication Errors

Despite an uncertain regulatory system, one thing is for sure: drug manufacturers have a duty to those who use their products. That duty requires that the medication they ingest is safe for human consumption. When a manufacturer’s drug causes unanticipated side effects, that manufacturer may be held liable to the patient taking the drug.

Have You Been Injured by a Dangerous Drug?

If you or a loved one has recently been injured after taking any kind of prescription medication, you may be entitled to damages from the manufacturer, the pharmacy, or both. In some cases, the law imposes a duty on pharmacists to warn patients about certain side effects. If this warning is not given, or if the pharmacist mis-fills the prescription, there may be a cause of action against the pharmacy. To find our more about the laws regulating pharmacies and drug manufacturers, speak to a dedicated Maryland prescription drug error attorney. At the law firm of Lebowitz & Mzhen, LLC, we have years of experience representing clients against pharmacies and drug manufacturers. Click here, or call 410-456-3600 to schedule an appointment with a dedicated pharmacy error attorney today.

More Blog Posts:

Colorado Man Recovers Over $10 Million in Pharmaceutical Error Case, Pharmacy Error Injury Lawyer Blog, May 7, 2014.

Pharmaceutical Company’s Failure to Warn Did Not Cause Plaintiff’s Injury, Court Rules, Pharmacy Error Injury Lawyer Blog, April 29, 2014.

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