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

Broad Range of Stakeholders Agree: Bipartisan, Bicameral Drug Quality and Security Act Will Improve Drug Safety, Should be Enacted As Soon As Possible

Saturday, September 28, 2013

WASHINGTON, D.C.—A broad range of stakeholders has endorsed the Drug Quality and Security Act, legislation introduced by Senate and House health policy leaders this week to address high-risk drug compounding practices and secure the pharmaceutical supply chain. The bill would improve drug safety and help prevent a future public health crisis like the 2012 meningitis outbreak tied to the New England Compounding Center.

Leaders for the Congressional health committees—Senate HELP Committee Chairman Tom Harkin (D-IA), HELP Committee Ranking Member Lamar Alexander (R-TN), House Energy & Commerce Chairman Fred Upton (R-MI) and Energy & Commerce Ranking Member Henry Waxman (D-CA) announced the agreementearlier this week; Senate HELP Committee members Al Franken (D-MN), Pat Roberts (R-KS), Michael Bennet (D-CO), and Richard Burr (R-NC) have worked on the bill throughout the process and are original cosponsors of the legislation. Read more about the bill here.

To date, groups including the American Society of Health-System Pharmacists, the Pew Charitable Trusts, the U.S. Chamber of Commerce, the National Community Pharmacists Association, the Federation of American Hospitals, Premier Healthcare Alliance, the American Medical Student Association, the American Public Health Association, the Annie Appleseed Foundation, the Association of State and Territorial Health Officials, the Center for Science and Democracy, the Union of Concerned Scientists, the Center for Medical Consumers, Community Catalyst, the Connecticut Center for Patient Safety, the National Association of County and City Health Officials, the Ovarian Cancer National Alliance, Trust for America’s Health, the Healthcare Distribution Management Association, the Pharmaceutical Distribution Security Alliance, the Generic Pharmaceutical Association, the Pharmaceutical Research and Manufacturers of America, PharMEDium, the Biotechnology Industry Organization, the National Association of Chain Drug Stores, Pfizer, UPS, and Richie’s Specialty Pharmacy have endorsed the Drug Quality and Security Act. Excerpts from those letters follow.

“We believe this bill helps clarify federal oversight of compounding outsourcing facilities, and seeks to create better communication channels between the Food and Drug Administration (FDA) and state boards of pharmacy. In the interest of patient safety we urge Congress to pass this legislation.” –American Society of Health-System Pharmacists

“The Pew Charitable Trusts supports the Drug Quality and Security Act, which represents a major advance for the security of U.S. drug distribution and a step toward regulatory clarity and higher quality standards for compounded medicines.” –The Pew Charitable Trusts

“The Chamber believes efforts to bolster oversight of compounding pharmacies and institute a federal prescription drug track and trace system are vital to protecting Americans against counterfeit drugs.  This bill would help alleviate confusion and reduce costs for businesses in the pharmaceutical sector, as well as improve the safety of patients generally.” – The U.S. Chamber of Commerce

“NCPA commends the Congress for crafting bipartisan legislation that addresses the New England Compounding Center (NECC) tragedy, ensures quality standards for all compounded pharmaceuticals, and maintains patient access to vital compounded medications.

“NCPA also supports efforts to strengthen our nation’s pharmaceutical supply chain through passage of strong security provisions. Small business community pharmacies already struggle to meet many regulatory requirements and can ill afford needless new mandates. Fortunately, this legislation takes this into consideration so pharmacists can focus on patients. We applaud Congress for crafting a single, uniform national supply chain solution that will establish one rigorous standard that will extend from coast to coast and provide greater safeguards for consumers.” –National Community Pharmacists Association

“The Drug Quality and Security Act is a positive step in the right direction. The bill offers the federal government clear and essential authority to oversee large pharmaceutical compounding companies. At the same time, it will enable hospitals to produce safe, reliable, and effective compounded pharmaceutical products for individual patients.”—the Federation of American Hospitals

“I am writing to express our appreciation for working to address the safety concerns of patients and providers regarding pharmaceuticals from compounding manufacturers in addition to establishing a uniform, national system for securing the pharmaceutical distribution supply chain.” –Premier Healthcare Alliance

“We urge you to pass the Drug Quality and Security Act without delay. This bill contains important provisions to protect consumers and patients. It creates a strong national unit-level serialization and traceability standard to keep unsafe medicines from reaching consumers.

“The bill is also a step forward in the longstanding effort to reduce the risks of drugs made by compounding pharmacies that exceed traditional practice. It restores key provisions of section 503A of the Food, Drug, and Cosmetic Act and creates a ‘voluntary category’ of outsourcing facilities that will enable hospitals and clinics to purchase drugs made under higher quality standards. Nearly every American family depends on medicines to prevent or treat illness.

“This bipartisan, bicameral legislation will help ensure that those drugs are safe, effective, and of the highest quality.” — the American Medical Student Association, the American Public Health Association, the Annie Appleseed Foundation, the Association of State and Territorial Health Officials, the Center for Science and Democracy, the Union of Concerned Scientists, the Center for Medical Consumers, Community Catalyst, the Connecticut Center for Patient Safety, the National Association of County and City Health Officials, the Ovarian Cancer National Alliance, the Pew Charitable Trusts, and Trust for America’s Health

“We finally have an opportunity to enact federal legislation to strengthen the security of the pharmaceutical supply chain […] it is critical that Congress act now to protect the safety of patients and security of the pharmaceutical distribution supply chain. Therefore, we urgently request that you move for consideration of the Drug Quality and Security Act, by both chambers as soon as possible, so that it can be signed by President Obama.” –Healthcare Distribution Management Association

“PDSA thanks the House Energy & Commerce and Senate HELP Committees for their tireless work on this legislation, which will better protect American consumers from the risk of counterfeit and adulterated medicines by implementing a single, uniform and national pharmaceutical supply chain system.

“We are pleased to support the supply chain traceability legislation that the Committees released yesterday.  We urge prompt passage of the legislation by the full House and Senate so it can be signed into law by President Obama as soon as possible.” –Pharmaceutical Distribution Security Alliance

“The current patchwork of State prescription drug supply chain laws has left our nation’s pharmaceutical supply vulnerable to the entry of counterfeit and adulterated prescription drugs, which threaten the health of patients and the integrity of our industry. That is why GPhA has worked with Congress to enact a single, uniform, and national pharmaceutical distribution supply chain law. The Drug Quality and Security Act establishes a uniform national standard for electronic prescription medicine tracking that will further safeguard our nation’s prescription drug supply. Americans deserve the predictability and reliability that this uniform federal standard will make possible.” –Generic Pharmaceutical Association

“We appreciate the collective leadership of the Senate Health, Education, Labor, and Pensions Committee as well as the House Energy and Commerce Committee in persisting with this effort to ensure a strong bill that protects patient safety and maintains supply chain integrity. This vital legislation will protect patients from counterfeit drugs by establishing a uniform, national system for securing the pharmaceutical distribution supply chain.

“Passage of this important bipartisan legislation, championed so effectively by broad, bipartisan groups of Members on both Committees, is a significant step in fighting against prescription drug counterfeiters, who have long placed our nation’s patients at risk. Support for this legislation includes a broad, multi-stakeholder coalition that spans the entire spectrum of the U.S. pharmaceutical distribution system, including manufacturers, wholesale distributors, third-party logistics providers, and pharmacists.”—Pharmaceutical Research and Manufacturers of America

“We believe this legislation represents an important step forward in clarifying the regulatory oversight of the entire spectrum of compounding operations and safeguarding against future outbreaks due to gaps in regulatory oversight.” –PharMEDium

“BIO members are committed to further strengthening the biopharmaceutical supply chain to protect patients from potentially counterfeit or adulterated drugs. To that end, we support the establishment of strong, uniform, scalable national standards for drug serialization and tracing systems contained in this legislation, rather than relying on the emerging patchwork of individual state mandates. We greatly appreciate your tireless efforts, along with the other members of the Committees, to craft this careful compromise.” –Biotechnology Industry Organization

“We support the agreement, which we believe will help guarantee patient safety through a more secure supply chain and appropriate and improved oversight of compounding activities.  We believe that the reforms contained within the legislation meet the overarching goal of protecting patients while allowing chain pharmacies to operate effectively and efficiently in dispensing needed medications.  

“We are pleased that the bill establishes one, national standard for supply chain regulation, as a patchwork of state laws and regulations would be unworkable.  Chain pharmacy has made significant investments to ensure that the U.S. pharmaceutical distribution system is one of the safest in the world and your legislation will only improve and strengthen the process for all stakeholders.

“The agreement’s clarification and additional regulatory track for sterile compounding is a large step in helping avoid tragedies such as last year’s national meningitis outbreak.  At the same time, we appreciate the agreement’s protection of traditional compounding practices largely performed by retail pharmacists.”–the National Association of Chain Drug Stores

“Patient safety is a top priority for Pfizer. This bill will increase the security of the United States’ already strong drug supply chain by creating a national traceability system and replacing the patchwork of state laws now in place. Specifically, this bill provides greater safeguards for patients by requiring the placement of unique serial numbers on each drug package, and tracking them as they move through the distribution system, lessening the threat of illicit and counterfeit medicines entering the drug supply chain. For these reasons, the time is now to pass this bill.” –Pfizer

“UPS strongly supports the final passage of the Drug Quality and Security Act. UPS appreciates and applauds the Senate Health, Education, Labor and Pension Committee's work toward bipartisan, bi-cameral legislation that will protect American consumers by creating a more secure pharmaceutical supply chain.” –UPS

“I have reviewed the [bill.] I find it to be reasonable and I support it. Its’ intent to maintain/reinforce the appropriateness of quality, evidence-based traditional pharmacy compounding services by preserving Section 503(A) of current law as it relates to State regulation of traditional pharmacy compounding as well as encourage/require increased communication between FDA and State boards of pharmacy are both incredibly important.”—Richie’s Specialty Pharmacy

 

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