Drug safety is now as American as apple pie, based on the 96-1 vote the Senate took to reauthorize the Prescription Drug User Fee Act (PDUFA). Few things pass through Congress with such overwhelming support, and we are heartened that Senators came together to pass this “must-pass” legislation.
Millions of Americans rely on medications every day, from people with chronic illness, to seniors, to anyone who takes a pill for allergies or a headache. As a member of the Alliance for a Safe Drug Supply, Community Catalyst has advocated for solutions to this critical issue. Assuming the House will also pass similar legislation and we’ll have a new law soon, one piece of the complicated health care puzzle will have been made safer. How do you spell relief? P-D-U-F-A.
Truly, the bill marks a momentous occasion for consumers. Today, roughly 80 percent of ingredients used in U.S. medicines are made overseas, and there has been a historic disparity between the number of inspections conducted at U.S.-based plants and foreign plants. Under the new bill, the fees paid by name-brand and generic drug manufacturers will allow more frequent inspection of foreign manufacturing sites that produce drugs imported into the United States, addressing a critical gap in supply chain safety. As Pharmalot notes, 12.7 percent of capsule makers in China were recently found to be making unsafe capsules. While it is unclear whether those particular capsules were being introduced to the international supply chain, as Ed Silverman so eloquently puts it, “the episode underscores the larger concern that some Chinese companies that are intertwined in the pharmaceutical supply chain operate as if China is a modern-day version of the Wild West.” Of course, there’s also been a drumbeat of recalls and egregious safety problems in U.S. plants—but we only know about them due to more inspections here in the U.S. Now we’ll have parity in foreign inspections, too.
The PDUFA bill also marks the first time the generic drug industry will be contributing to the FDA’s inspection and oversight funds, pitching in nearly $1.6 billion over the next five years. We view this commitment from generic pharmaceutical producers as a notable contribution to ensuring the safety of the effective, affordable generics that we all rely on today.
In addition, the bill requires pharmaceutical companies to track each batch of drug products along the supply chain, from the factory to the pharmacy or hospital. This has been a long-sought after consumer protection, given that “track and trace” systems can be utilized to ensure counterfeit drugs are not introduced into the supply chain. Prescription drug counterfeiting is one of the most lucrative crimes in the world, and the infamous heparin contamination is believed to have been economically-motivated. And although it is relatively rare in the United States, there are far too many instances of intentionally-adulterated or counterfeit medications having breached the supply chain and been consumed by Americans, and we need to put an end to it.
One more piece of good news is the updated system to proactively address drug shortages. According to the Pew Health Group, more than 200 drugs went through periods of shortages in 2011. The bill puts in place an early warning system that manufacturers must inform FDA in advance of discontinuing manufacture of any drug. Hopefully, patients receiving cancer treatment will soon be able to cross one thing off their list of worries.
The bill was not perfect, however. Patients would greatly benefit from the earliest possible access to generic drugs when brand name patents end, so we were disappointed that the “pay-for-delay” amendment was defeated. Additionally, there are grave concerns about medical device safety, and we are disappointed that the Senate did not authorize medical device user fees to be used to evaluate the safety of devices in the market, despite the many recalls of dangerous devices in the past few years.
While there is room for improvement, we applaud the FDA, the Senate, and drug manufacturing companies for working together to pass this legislation, and eagerly await the House to follow suit.
-- Anna Dunbar-Hester, Program Coordinator and Policy Analyst