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.”
- Date added:
- Jul 24, 2012
As multidrug-resistant infections have grown more prevalent, few new antibiotics are reaching the market. This is attributed, in part, to the economic and regulatory challenges associated with their development. Recently, stakeholders have endorsed a novel regulatory pathway to approve these lifesaving drugs for use in limited patient populations — namely those at highest risk and with few or no other options.More info
''A subsidiary of India's largest pharmaceutical company has agreed to pay a record $500 million in fines and penalties for selling adulterated drugs and lying to federal regulators in a case that is part of an ongoing crackdown on the quality of generic drugs flowing into the U.S."More info
"As differing bills for securing the pharmaceutical supply chain wind their way through the US House and Senate, a key hurdle to passing legislation may have just been cleared. Earlier this week, the National Community Pharmacists Association – which is a member of an influential industry coalition that has been floating its own proposals – is now willing to back either bill."More info
"U.S. senators considering fundamental changes to how the practice of pharmacy compounding is regulated heard almost unanimous support for reform at a Washington committee hearing Thursday."More info
"At least 67 people have died in 20 outbreaks caused by contaminated drugs since 2001, experts told a Senate hearing Thursday. The Food and Drug Administration says there have likely been more cases than that, but they have no way of telling now."More info
"State pharmacy officials on Thursday threw their support behind a proposal giving the Food and Drug Administration authority over large compounding pharmacies, in an effort to head off more outbreaks tied to contaminated medications."More info
The U.S. Senate Committee on Health, Education, Labor and Pensions held a hearing on May 9 entitled "Pharmaceutical Compounding: Proposed Legislative Solution." Pew's Allan Coukell, a pharmacist and drug safety expert, testified on the need to strengthen oversight of the compounding industry.More info
When a doctor sticks a needle in you, you expect that the drugs it carries won’t be tainted. But, possibly owing to a strange gray area in federal law, thousands of patients last October got injections for back pain that contained highly dangerous fungal meningitis, and dozens of them died. Members of the Senate Health, Education, Labor and Pensions Committee are now seeking to fix the government’s oversight of the obscure world of compounding pharmacies. The reforms they want are overdue.More info
"As a nation, we need to exercise greater care with our use of antibiotics, in both humans and animals, so that these medications remain effective in treating serious bacterial infections."More info
The U.S. Food and Drug Administration (FDA) has issued a proposed rule that would require manufacturers of medical devices, with certain exceptions, to place a unique identifier on the label of medical devices. Some medical devices would also need to be directly marked with the unique identifier.More info
The Pew Charitable Trusts commented on the draft proposal to secure drug distribution in the United States. Although recognizing that the draft is the product of a sustained effort to address a complex system and balance sometimes competing imperatives, Pew shared areas of significant concern.More info
The three co-chairs of the New Democrat Health Care task Force – Reps. Allyson Schwartz, Kurt Schrader and Bill Owens – sent FDA a letter inquiring about the status of the agency’s final regulations to establish a unique device identifier (UDI) system and database.More info
The House Energy & Commerce Subcommittee on Health will hold a hearing on April 25 entitled "Securing Our Nation’s Prescription Drug Supply Chain." Allan Coukell, a pharmacist and drug safety expert, will testify on the need to establish a national system to track and authenticate medicine. The principles outlined in his prepared testimony are supported by other stakeholders in statements from consumer, patient, public health, and industry groups.More info
The Pew Charitable Trusts has identified 20 pharmacy compounding errors associated with 1022 adverse events, including 75 deaths, since 2001.More info