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Protects Patients and Improves Oversight Regulation of Compounded Drugs

Press Release

Location: Washington, DC

U.S. Senator Pat Roberts today said the Senate Health, Education, Labor and Pensions (HELP) Committee favorably reported out bipartisan legislation he co-wrote to protect patients and improve regulation of the pharmacy compounding industry after a meningitis outbreak killed 55 people and sickened hundreds more. The bill now heads to the Senate floor for debate and a vote by the full Senate.

The bill, the Pharmaceutical Compounding Quality and Accountability Act was introduced by Senator Roberts, Chairman of the HELP Committee Senator Tom Harkin (D-IA), HELP Ranking Member Senator Lamar Alexander (R-TN) and Senator Al Franken (D-MN) after months of negotiation and stakeholder review.

"Status quo is unacceptable folks," Roberts said. "Saying that the current law is satisfactory or preferable to anything we have done in this legislation is nonsense, because under that construct in one instance we have 55 people who have lost their lives and over 700 people who became ill, some who are still suffering. And unfortunately that isn't the only occurrence in the last 10 years. I urge my colleagues to work with us to bring this bill to the floor immediately."

The HELP Committee staff also released their Oversight and Investigation Report finding that large-scale drug compounders, who are currently regulated similarly to state-licensed community pharmacies, continue to pose a serious risk to public health.

In the eight months since the NECC-caused meningitis infections, at least 48 compounding companies have been found to be producing and selling drugs that are contaminated or created in unsafe conditions.

"This report details a shocking failure to act. A failure to act by NECC to protect their patients; a failure by MA Board of Pharmacy to pull the license of an entity with repeated compliance issues; a failure to act by the FDA to see beyond the bureaucracy and red tape that defines them, and to use the authority they had or share the information they were in possession of to protect patients and the public health. There was a failure to act by Congress who has recognized the lack of clarity on these issues over a decade ago and could have potentially averted this crisis," Roberts said. "I've been working with Members like Senator Burr for years to gain momentum on these issues, and through the leadership of Chairman Harkin, Ranking Member Alexander and Senator Franken we are putting forth legislation to address these failures and ensure clarity in the future to avoid another crisis and put patients first."

The legislation is supported by a wide range of stakeholders including Premier Healthcare Alliance, Federation of American Hospitals (FAH), Council on Radionuclides and Radiopharmaceuticals, Inc. (CORAR), American Society of Health-System Pharmacists (ASHP), The Pew Charitable Trusts, National Association of Boards of Pharmacy (NABP) and National Association of Chain Drug Stores (NACDS).

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