A Healthy Dose of Bipartisanship
As the U.S. Supreme Court wrestled with one of the most polarizing healthcare issues of our time, Congress quietly addressed another important health issue — with overwhelming bipartisan support.
With the help of a broad array of stakeholders from the private sector, the medical community, and consumer advocates, new legislation will solve pressing problems facing American patients, including contaminated medicines counterfeited overseas that have been infiltrating our drug supply; drug-resistant “superbugs” that are evolving faster than we can create new drugs to fight them; and faulty medical devices implanted in thousands of patients that are failing at an unacceptable rate.
Passed by Congress on June 26 and signed by President Obama on July 9, the FDA Safety and Innovation Act will increase inspections of foreign manufacturers that supply 80 percent of the ingredients in our pharmaceuticals, putting American companies on the same footing as their foreign competitors. In addition, it requires drug makers to hold their suppliers to high standards.
Seventy years after penicillin was first used to save U.S. troops, this legislation will spur the development of new — badly needed — antibiotics. Today, a growing number of Americans, including wounded military personnel in particular, are suffering hard-to-treat, drug-resistant infections. In fact, more Americans now die from just one type of drug-resistant infection than from HIV/AIDS. But because these drugs produce less revenue than many other medicines, pharmaceutical companies have been leaving the market instead of expanding it. The new law helps address that by ensuring that innovative companies have more time to recoup their investment costs.
This legislation is intended to alleviate the challenge of drug shortages, and it includes provisions to bring generic drugs to market more quickly, which will help reduce the federal deficit by several hundred million dollars over ten years. And the bill will help the one in 25 Americans with an implanted medical device, like a hip implant or a cardiac defibrillator, by improving the FDA’s ability to monitor them for safety problems.
As comprehensive as it is, of course the new law is not a cure-all. Congress left out of the bill a national system to detect counterfeit and stolen drugs, such as the fake vials of the cancer drug Avastin recently sold by a Tennessee wholesaler, and the truckload of stolen insulin that later turned up in pharmacies in several states. This is a growing concern: between 2000 and 2010, the number of annual counterfeit drug investigations opened by the FDA grew from six to 72.
Tracking drugs at a bottle-by-bottle, vial-by-vial level is not only necessary, but feasible, as evidenced by the fact that similar programs are already in place around the world. Turkey, for example, is requiring unit-level drug tracking. And California has established similar requirements for companies doing business in that state. Fortunately, lawmakers are already looking ahead for other opportunities to put a similar drug tracking system into place nationwide.
Clearly, there is — and will always be — more work to do, but we should take a moment to toast Congress’ bipartisan achievement: “To our health.”
The House Energy and Commerce Subcommittee on Oversight and Investigation held a hearing on Feb 16 entitled "Counterfeit Drugs: Fighting Illegal Supply Chains." Elizabeth Jungman, director of drug safety and innovation testified on counterfeit drugs the importance that newly passed Drug Quality and Security Act will have on the safety of the U.S. pharmaceutical supply chain.
The following case studies illustrate breaches to the pharmaceutical supply chain—the route a drug travels from its raw material origins to the delivery of a finished medicine. These examples, all of which are discussed in Pew Health Group’s report After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs, demonstrate the different ways in which contaminated, fake, or otherwise unsafe medicine can reach patients, and underscore the need for reform. More info
The Pew Charitable Trusts sent a letter to Representatives Phil Gingrey (R-GA) and Gene Green (D-TX) of qualified support of the Antibiotic Development to Advance Patient Treatment (ADAPT) Act, a welcome step towards establishing a new regulatory pathway to bring desperately-needed antibiotics to the patients who need them most. The letter was also signed by 31 organizations representing healthcare providers, hospitals, pharmacists, clinical laboratory scientists and medical microbiologists, public health experts, patients and advocates. More info
The landmark Drug Quality and Security Act was signed into law in late 2013 to address these risks and to create a new national framework for securing the drug distribution supply chain. Title II of the law, the Drug Supply Chain Security Act, establishes a national system to enable supply chain partners and regulators to trace back each package of a drug from the pharmacy where it is dispensed to the manufacturer. More info
The Pew Charitable Trusts drafted a letter to the HIT Policy Committee, Meaningful Use Workgroup of the Office of the National Coordinator for Health Information Technology regarding the new meaningful use objective for the capture of unique device identifiers (UDIs) in electronic health records (EHRs). In the letter, Pew asks the committee to consider how the proposed objective for UDI capture advances several goals of the meaningful use program and addresses feedback previously provided. More info
On Nov. 27, 2013, President Barack Obama signed the landmark Drug Quality and Security Act, a new law designed to improve safety within the U.S. pharmaceutical supply by addressing these risks. Title I of the act contains important updates to oversight systems for pharmaceutical compounding. Compounding—the creation of customized medicines to meet patients’ unique needs—is traditionally practiced by pharmacies and regulated by state authorities. Over the years, this activity has expanded to include companies that compound medicine on a large scale but do not undergo the same scrutiny given to pharmaceutical manufacturers. More info
On January 31, Pew submitted comments to the U.S. Food and Drug Administration in response to draft guidance on the implementation of Title I of the Drug Quality and Security Act and addressed five topics: anticipatory and office stock compounding; quality standards; FDA / state coordination; MOUs to address inordinate interstate shipment of compounded drugs; use of bulk drug substances. More info
The FDA wants to create an expedited approval pathway for high-risk medical devices for unmet needs, saying current tools at its fingertips are ineffective for speedier approvals. More info
For patients in the United States with serious medical conditions, access to new medical technologies can make the difference between life or death. Those patients rely on new devices—such as implantable pacemakers or new cancer diagnostics—to treat, cure, or diagnose debilitating or life-threatening conditions. More info
On Dec. 12, 2013, a bipartisan bill was introduced in the U.S. House of Representatives to encourage development of antibiotics for patients with serious or life-threatening bacterial infections. The new legislation would direct the U.S. Food and Drug Administration, or FDA, to approve new antibiotics and antifungal drugs for specific, limited populations of patients who have infections for which few or no suitable options exist. More info
In the State of the Union address, President Barack Obama recognized the need to “stay ahead of drug-resistant bacteria” and that developing therapies to fight these threats is an opportunity for American innovation and discovery. The threat of drug-resistant bacteria is real, and the need for antibiotic development clear. More info
On Thursday, January 30, The Pew Charitable Trusts will hold an interactive conference with leading experts from FDA, the Centers for Medicare & Medicaid Services (CMS), the medical device industry, patients, consumers, private payors and other key health policy stakeholders to explore patient access to devices for unmet medical needs. More info
On Nov. 27, President Barack Obama signed the landmark Drug Quality and Security Act, a law that aims to improve the safety of the U.S. pharmaceutical supply. Title I of the act contains important updates to oversight systems for pharmaceutical compounding, and on Dec. 3, the U.S. Food and Drug Administration, or FDA, released for public comment six guidance and regulatory documents for implementing the new law. More info
A small number of U.S. compounding pharmacies have begun registering with the Food and Drug Administration under new legislation designed to tighten control of the custom medication makers following a deadly outbreak of fungal meningitis linked to a pharmacy in Massachusetts. More info
A bipartisan group of representatives introduced in the U.S. House of Representatives a bill that would create an accelerated approval pathway for antibiotics and antifungals for use in limited populations and would update the criteria that HHS uses to determine breakpoints for drugs. More info