US Senate Committee on Health, Education, Labor, & Pensions

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Harkin: Signing of Bipartisan Health Bills is Culmination of Major HELP Committee Efforts

Pharmaceutical Compounding and Drug Supply Chain Bills, CHIMP Act Amendments, PREEMIE Reauthorization Cleared by Committee Earlier This Year

Wednesday, November 27, 2013

WASHINGTON, D.C.—Senator Tom Harkin (D-IA), Chairman of the Senate Health, Education, Labor, and Pensions (HELP) Committee, issued the following statement after President Obama signed several bipartisan health bills into law today, including the landmark Drug Quality and Security Act (DQSA), which Harkin introduced and led to passage in the Senate on November 18, 2013. The President also signed into law a package of bipartisan health bills, including the CHIMP Act Amendments of 2013, and the PREEMIE Reauthorization Act – both approved by the HELP Committee earlier this year – and the National Pediatric Research Network Act. That package of bills, under the title of S.252, cleared the Senate on November 15, 2013.

 “Today is the culmination of meaningful bipartisan work by the HELP Committee to pass critical measures that support and protect public health,” Harkin said. “Chief among the bills signed by the President today is the Drug Quality and Security Act, which represents a strong and thoughtful response to the tragic 2012 meningitis outbreak tied to the New England Compounding Center. This legislation will dramatically improve the safety of compounded drugs and will also establish an unprecedented tracing system that will track prescription drugs from manufacturing to distribution.

 “I am encouraged by the Committee’s growing record of accomplishments, and look forward to continuing our work with members of both parties on the HELP Committee to pass meaningful legislation that will positively impact our public health and improve the lives of Americans,” Harkin added.

 The Drug Quality and Security Act clarifies current federal law regarding pharmacy compounding and resolves the patchwork of current federal regulation by applying a uniform standard nationwide. Compounders who wish to practice outside the bounds of traditional pharmacy practice can register as outsourcing facilities, but those who choose to remain traditional pharmacies will continue to be regulated primarily by state boards of pharmacy, as they are in current law. Outsourcing facilities would be subject to oversight by the U.S. Food and Drug Administration (FDA) in much the same way as traditional manufacturers are monitored. FDA will know who these outsourcers are and what they are making, receive adverse event reports about compounded drugs, and have the authority and resources to conduct risk-based inspections. 

 The second title of the Drug Quality and Security Act would replace today’s patchwork of state prescription-drug tracing laws by creating a new uniform framework for tracking drugs from the manufacturer to the pharmacy. There is currently no system for tracking the drugs that make up some four billion prescriptions per year in the United States, which means drugs that are stolen or counterfeit may not be discovered before reaching consumers. Read more about the bill here.

 The CHIMP Act Amendments will ensure that chimpanzees owned or supported by the National Institutes of Health (NIH) that are no longer used for medical research can continue to receive the care they need in quality settings. The new law will provide flexibility for the U.S. Secretary of Health & Human Services to use already-appropriated funds to pay for care of chimpanzees housed in federal sanctuaries if doing so would be more efficient and economical for the NIH.

 The PREEMIE Reauthorization Act, cleared by the Senate HELP Committee in February,authorizes the Centers for Disease Control and Prevention and the Health Resources and Services Administration to conduct research and education activities relating to preterm labor and delivery and infant mortality, while the National Pediatric Research Network Act allows for the establishment of a national pediatric research network by the NIH dedicated to finding treatments and cures for pediatric diseases and conditions.

Earlier this month, the Senate approved the Children’s Hospital GME Support Reauthorization Act (CHGME), which supports graduate medical education at children’s hospitals around the country, and gives children’s health a critical boost by growing the number of doctors who choose to become pediatricians and pediatric specialists. That bill, which cleared the Senate HELP Committee in October, has been sent to the House for consideration.  

On November 12th, Congress approved the HIV Organ Policy Equity (HOPE) Act—passed by the Senate HELP Committee in March—to allow research on organ donation from HIV-positive organ donors into HIV-positive recipients.  That bill was signed into law last week. Also on November 12th, Congress approved legislation that passed the Senate HELP Committee in October, to allow access to emergency epinephrine in schools. That legislation, the School Access to Emergency Epinephrine Act, was signed into law by President Obama on November 13th.  

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