Letter to Representative Markey in Support of Legislation that Would Give the FDA Authority to Oversee Compounding Pharmacies, October 31, 2012

October 31, 2012

The Honorable Edward J. Markey
Energy and Commerce Committee
U.S. House of Representatives
2108 Rayburn
Washington, DC 20515

Dear Congressman Markey,

As members of the Patient, Consumer, and Public Health Coalition, we thank you for your commitment to the health of patients and consumers by introducing the Verifying Authority and Legality in Drug (VALID) Compounding Act of 2012. This bill would strengthen FDA oversight of compounding pharmacies in several essential ways, and is clearly needed to prevent tragedies such as the contaminated steroid injections that have already resulted in 356 cases of fungal meningitis and 28 deaths.

The current laws and regulations regarding compounding pharmacies have resulted in giant loopholes that allow medical products that are neither safe nor effective to be sold throughout the country, putting patients’ lives at risk. We are very grateful to you for your leadership on this very important, life-saving bill.

The VALID Act would protect the activities of traditional small compounding pharmacies while ensuring that compounding pharmacies that are essentially operating as drug manufacturers are regulated by the FDA the same way as other drug manufacturers. It would require pharmacies that engage in interstate commerce to register with the FDA and comply with minimum safety standards. The bill would require compounding pharmacies to report deaths and other serious adverse events to the FDA in a timely manner, so that other patients would not be harmed. It would authorize the FDA to inspect pharmacy facilities, which is absolutely essential. It would also require a warning to patients that compounded drugs have not been approved safe and effective by the FDA.

We look forward to working with you on the VALID Act, and share your desire to make sure that waivers are available when the public health is at stake, but are not used to undermine the integrity of the legislation.

The scandal around the lack of oversight of compounding pharmacies has alarmed lawmakers on both sides of the aisle.  We will make every effort to secure bipartisan support for this bill.

Cancer Prevention and Treatment Fund
Jacobs Institute for Women’s Health
National Consumers League
National Research Center for Women & Families
Our Bodies Ourselves
Union of Concerned Scientists

The original letter can be found here.

Press release from Representative Markey.

November 1, 2012
Washington, D.C.

VALID Compounding Act will give FDA authority it needs to ensure the safety of the compounding pharmacy sector nationwide

Today, Congressman Edward J. Markey (D-Mass.) announced legislation he plans to introduce tomorrow that will strengthen federal regulations for compounding pharmacies. The New England Compounding Center (NECC), a compounding pharmacy located in Rep. Markey’s Congressional District, has been found to be the source of contaminated injectable steroids that have led to 28 deaths and 377 illnesses in 19 states. The Verifying Authority and Legality in Drug (VALID) Compounding Act will give the Food and Drug Administration (FDA) clear, new authority to oversee compounding pharmacy practices throughout the country.

“Compounding pharmacies have been governed by fragmented regulations for too long, leading to the worst public health disaster in recent memory,” said Rep. Markey, senior member of the Energy and Commerce Committee. “The VALID Compounding Act ends this regulatory black hole by giving the FDA new, clear authority to protect patients and oversee these companies. I look forward to working with my colleagues in Congress on a bipartisan basis to move this legislation forward.”

A copy of the VALID Compounding Act can be found HERE. A one-page description of the legislation can be found HERE.

The VALID Compounding Act will:

  • Preserve state regulatory authority for traditional small compounding pharmacy activities;
  • Ensure that compounding pharmacies that are operating as drug manufacturers are regulated by the FDA as drug manufacturers;
  • Allow compounding pharmacies with a legitimate reason to compound drugs before the receipt of a valid prescription to request a waiver to enable them to do so;
  • Allow the FDA to waive the requirement to compound drugs solely for individual patients with valid prescriptions in the event of a drug shortage or to protect public health;
  • Allow the FDA to waive the requirement to compound drugs only if they are not copies of commercially-available drugs if doing so is necessary to protect public health or well- being; and
  • Increases transparency to the public by mandating that compounded drugs be labeled to ensure that recipients know that the drugs have not been tested for safety or effectiveness, publishing a “Do Not Compound” list of unsafe or ineffective drugs, and reporting of bad reactions to compounded drugs or any drug that poses a safety risk.

“This bill will save lives by ensuring that compounding pharmacies play by the rules that are essential to protect patients,” said Diana Zuckerman, PhD, president of the Cancer Prevention and Treatment Fund. “This month’s tragic meningitis outbreak from contaminated steroid injections was absolutely preventable. We call on Congress to work in a bipartisan manner to pass Congressman Markey’s legislation, which is necessary to protect our families from these predictable, preventable tragedies.”

The legislation has been endorsed by Cancer Prevention and Treatment Fund, Jacobs Institute for Women’s Health, National Consumers League, National Research Center for Women & Families, Our Bodies Ourselves, and Union of Concerned Scientists. A copy of the endorsement letter can be found HERE.

Earlier this week, Rep. Markey released the report “Compounding Pharmacies, Compounding Risk”, which revealed that even before the current outbreak, problems at compounding pharmacies led to at least 23 deaths and 86 illnesses in 34 states, and that state regulatory bodies typically focus on more non-safety related traditional pharmacy licensing activities. A timeline of Rep. Markey’s work on compounding pharmacies can be found HERE.