Working Group on Pharmaceutical Safety

President Obama signed H.R. 3204, the Drug Quality and Security Act, into law on November 27, 2013.

In 2014, the Working Group on Pharmaceutical Safety is continuing its efforts to ensure proper oversight of compounding pharmacies, focusing its efforts on ensuring strong implementation of the new law.

WORKING GROUP ON PHARMACEUTICAL SAFETY PRAISES SENATE PASSAGE OF H.R. 3204, THE DRUG QUALITY AND SECURITY ACT

WASHINGTON – The Working Group on Pharmaceutical Safety today released the following statements regarding Senate passage of the Drug Quality and Security Act.

 

Statement from Governor Tommy Thompson:“We commend the bipartisan leadership in the House and Senate for their tireless work on this important bill, which provides necessary federal oversight of pharmaceutical quality while preserving the important role of traditional compounding.  This legislation meets the commonsense expectations of patients, who deserve the peace of mind that the drugs they are taking are safe.” 

 

Statement from Sarah Sellers, PharmD, MPH: “This legislation is an historic accomplishment that is long overdue.  Sadly, it is not the end for the many families who have lost loved ones or continue to live with the debilitating effects of contaminated drugs that lacked appropriate oversight.  Moving forward, the challenge for lawmakers, patient advocates, and the public health community is to ensure that this comprehensive legislation is appropriately implemented, and that state and federal regulators have the resources they need to support necessary surveillance and enforcement priorities.”

 

Background on Working Group Leadership:

 

Governor Tommy Thompson serves as a co-leader of the Working Group on Pharmaceutical Safety. Thompson served as U.S. Secretary of Health and Human Services (HHS) from 2001 to 2005, Governor of Wisconsin from 1987 to 2001, and has solved major healthcare delivery, safety and regulatory problems at the federal and state levels. He is currently Chairman of TherapeuticsMD.

 

Sarah Sellers, PharmD, MPH, serves as a co-leader of the Working Group on Pharmaceutical Safety. She is a former Research Fellow in FDA’s Office of Compliance and Safety Reviewer in FDA’s Office of Safety and Epidemiology. Dr. Sellers is a widely respected pharmacoepidemiologist and advisor on safety concerns related to both FDA-approved and pharmacy compounded drugs. Currently the President of q-Vigilance, LLC, Dr. Sellers has advised pharmaceutical companies on benefit-risk concerns related to compounded copies of FDA-approved medications in the marketplace.

Poll Finds Strong Support for Effective FDA Regulation of Compounding Pharmacies

As Congress considered legislation to address the oversight of compounding pharmacies, the Working Group on Pharmaceutical Safety released an independent survey highlighting the large gap between voters' expectations  that the medications they receive are FDA-approved and loopholes in federal law that enable some pharmacies to avoid Food and Drug Administration (FDA) regulation. The results of the survey were released one year after contaminated drugs produced at a compounding pharmacy – the New England Compounding Center (NECC) – caused a deadly fungal meningitis outbreak that has claimed 64 deaths nationwide and sickened more than 700 others.

 

Key Findings Include:

  • 87% say it is very important for their doctor to inform them if they prescribe non-FDA approved prescription drugs
  • 83% say if their doctor would like to prescribe a drug for them that is not FDA-approved, it is very important for their doctor to tell them about FDA-approved alternatives, if one exists
  • 77% are concerned that the FDA does not verify the safety, effectiveness, or manufacturing quality of compounded drugs
  • 86% are concerned that not every prescription drug sold to patients in the United States has been reviewed and approved by the FDA
  • 77% support legislation to give the FDA more authority to regulate compounding pharmacies and compounded drugs

 

To download the full survey, click here.

 

To view the press release, click here.

Closing the Dangerous Loopholes that Allow for Mass Manufacturing Under the Guise of Pharmacy Compounding

The Working Group on Pharmaceutical Safety was created to address serious gaps in current policy that have led to a dangerous increase in the volume of mass-manufactured pharmaceutical products in the United States created under the guise of pharmacy compounding.

 

In consultation with patient advocates, public health officials, medical professionals and pharmaceutical companies, the Group is committed to finding workable policy solutions to reduce patient exposure to non-medically necessary compounded drugs. These products do not meet federal safety, efficacy and quality standards, and may be unsafe or ineffective.

 

The Group believes that the preventable cases of patient harm due to medications manufactured by compounding pharmacies are an unnecessary risk to the public health, and should be urgently addressed by policymakers. Clarifying the authority between federal oversight of pharmaceutical manufacturing and state oversight of pharmacists will help reduce current risks to public safety and improve the overall safety and security of the nation’s drug supply.


Learn more about current loopholes that threaten the safety of the U.S. drug supply.

Lethal Medicine Linked to Meningitis Outbreak

More than 17,000 vials of drugs were shipped to 23 states in Fall 2012. The supposedly sterile drug set off a disaster, ultimately killing 64 people and affecting over 750 other patients due to a fungus in the medicine.

 

 

 

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© 2013 Working Group on Pharmaceutical Safety