Stop Pharmaceutical Facilities From Distributing Tainted Drugs

ID-100128772

Target: State Representative Rosa DeLauro and members of Congress

Goal: Ensure safety regulation of compounding pharmacies.

The Food and Drug Administration (FDA) recently released a report on its investigation of compounding pharmacies, spurred by a 2011 meningitis outbreak that killed 51 people and sickened over 700 others. Compounding pharmacies  combine various drugs together to produce customized medications – a process which calls for well-sanitized environments. Of the 31 facilities investigated by the FDA, all but one violated safety standards. The FDA discovered rust and mold in rooms that were supposed to be sterile, poor ventilation systems, and employees wearing non-sterile lab coats and using their bare hands to handle sterile equipment.

The meningitis outbreak that prompted the investigation has been traced back to a steroidal pain medication produced by the New England Compounding Center in Massachusetts. The evidence revealed in the FDA report – combined with the number of infections – has raised many questions as to who is at fault.

It appears that compounding pharmacies are in a legal gray area when it comes to regulation.  This is because their operations are traditionally regulated by state pharmacy boards, not falling under FDA jurisdiction. In addition, the growth rate of the entire pharmaceutical industry has turned smaller facilities into large-scale operations that sell mass-produced drugs across the country. This increases the likelihood for outbreaks similar to the meningitis case that spread from Massachusetts to Ohio and Michigan. Because the compounding pharmacies have an obvious monetary stake in keeping the government out of their business, lobbyists and lawsuits have also made it difficult for the FDA to pursue investigation and regulation.

In order to ensure proper investigation of dangerous facilities and adequate protection of consumers in the future, the FDA needs legislation guaranteeing its authority over compounding pharmacies. Last year Representative DeLauro introduced the ‘Supporting Access to Formulated and Effective (SAFE) Compounded Drugs’ Act, which would require facilities to register with the FDA, ensure proper labeling of products, set minimum operation standards, and provide training to employees. Unfortunately, the bill did not pass and has not yet been reintroduced. Sign the petition below to tell Rep. DeLauro and Congress to pass this bill to protect the health and safety of Americans.

PETITION LETTER:

Dear Representative Rosa DeLauro and members of Congress,

The Food and Drug Administration recently released a report on its investigation of 31 compounding pharmacies of which all but one were found in violation of safety standards.  The FDA discovered rust and mold in rooms that are supposed to be sterile, poor ventilation, and employees wearing non-sterile lab coats and using their bare hands to handle sterile equipment.

It is these types of conditions that led to the 2011 meningitis outbreak, which has been traced back to steroidal pain medication produced by the New England Compounding Center in Massachusetts. The tainted drugs have killed 51 people and sickened over 700 so far. The evidence revealed in the FDA report combined with the number of infections has raised many questions as to who is at fault, especially considering the FDA backlog of complaints regarding the Massachusetts facility. It appears that compounding pharmacies are in a legal gray area when it comes to regulation because their operations are considered pharmacy work traditionally regulated by state pharmacy boards, not drug manufacturing which would fall under FDA jurisdiction. In addition to this classification, the growth rate of the entire pharmaceutical industry has turned smaller facilities into large-scale operations that sell mass-produced drugs across the country. This increases the likelihood for outbreaks similar to the meningitis case, which spread from Massachusetts to Ohio and Michigan. And because the compounding pharmacies have an obvious monetary stake in keeping the government out of their business, lobbyists and lawsuits have also made it difficult for the FDA to pursue investigation and regulation.

Regardless of the finger-pointing, the fact remains that no one should be unwittingly subjected to dangerous and even fatal drugs produced by an unregulated pharmaceutical industry. Last year Representative DeLauro introduced the Supporting Access to Formulated and Effective (SAFE) Compounded Drugs Act, which would require facilities to register with the FDA, ensure proper labeling of products, set minimum operation standards, and provide training to employees. We are demanding that this bill be reintroduced and passed in order to ensure swift investigation of dangerous facilities and adequate protection of consumers in the future.

Sincerely,

[Your Name Here]

Photo credit: Baitong333 via FreeDigitalPhotos

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