Rep. Ed Markey (D-Mass.) today praised the legislative package to clean up Massachusetts' compounding pharmacy industry announced by Massachusetts Governor Deval Patrick as a vital step that will protect patients and reform the industry in the Bay State. Governor Patrick's legislation serves as a robust state complement to federal legislation that Rep. Markey has introduced to ensure that strong standards will be applied to compounding pharmacies across the country.
"Governor Patrick's legislation will ensure that Massachusetts compounding pharmacies do not hurt more families, and my legislation cleans up compounding pharmacies in the rest of the country as well," said Rep. Markey. "These two actions on the state and federal level will serve as a one-two punch against the failings of the compounding industry and protect the health of patients everywhere."
These actions follow from one of the worst public health disasters in recent memory. Tainted drugs were sent by New England Compounding Center (NECC) -- a compounding pharmacy located in Rep. Markey's Congressional District -- and led to 39 deaths and 656 illnesses in 19 states.
A report released by Rep. Markey entitled "Compounding Pharmacies, Compounding Risk" revealed that even before this most recent 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.
Responding to this incident, Rep. Markey in November introduced the Verifying Authority and Legality in Drug (VALID) Compounding Act that will give the Food and Drug Administration (FDA) clear, new authority to oversee compounding pharmacy practices throughout the country. Governor Patrick's legislation will address compounding pharmacies at the state level, cleaning up the industry within Massachusetts borders. Rep. Markey is preparing to re-introduce a new version of this bill in the 113th Congress.
A copy of the VALID Compounding Act can be found HERE. A one-page description of the legislation can be found HERE.
A letter of support from Massachusetts Governor Deval Patrick 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.
The VALID Act has been endorsed by Union of Concerned Scientists, The Endocrine Society, Cancer Prevention and Treatment Fund, Jacobs Institute for Women's Health, National Consumers League, the National Research Center for Women & Families, Our Bodies Ourselves and HONOReform Foundation. A copy of the endorsement letter can be found HERE.