From the beginning of Thursday’s House hearing on ways to solve the generic drug shortage, it appeared obvious that little agreement was going to be reached on the best solutions to the problem.
“After months of pleading by the Democratic members of this subcommittee, we’re finally having a legislative hearing on drug shortages in our country,” Rep. Anna Eshoo (D-Calif.), ranking member of the House Energy & Commerce Health Subcommittee, said in her opening statement. “I’ve been frustrated by our subcommittee’s inaction through the spring and summer as I heard from so many physicians in my congressional district, and read about cancer patients, especially children, left behind due to shortages in life-saving treatments.”
Eshoo was especially critical of a “discussion draft” of legislation known as the Stop Drug Shortages Act sponsored by Rep. Cathy McMorris Rodgers (R-Wash.), chair of the full Energy & Commerce Committee. “This proposal mostly studies the problem with more reports,” she said. “Where the proposal has actionable policy, I think it’s a grab bag of talking points … The [bill’s] proposed inflation rebate policy misunderstands the market failure that caused drug shortages.”
McMorris Rodgers defended the bill. “The discussion draft focuses primarily on generic, sterile, and injectable drugs for a serious disease or condition and getting these drugs out from under mandatory 340B [drug discount program] rebates and inflation penalties,” she said, referring to the 340B drug discount program for hospitals that serve a large proportion of uninsured and underinsured patients. “We require CMS to launch a model that tests market-based pricing policies for these drugs in Medicare as well. The discussion draft also looks into how we can bring transparency to current contracting practices through new 340B guidance and disclosure reporting for group purchasing organizations.”
Subcommittee chair Brett Guthrie (R-Ky.) summarized the extent of the problem. “In 2022 alone, there were 301 drugs in active shortage, according to the University of Utah,” he said. “For over a decade, professionals in the medical and regulatory community have sounded the alarm on the underlying economic causes of drug shortages.”
“Unforeseen circumstances like a tornado hitting a pharmaceutical warehouse in North Carolina, or a manufacturing facility in India shutting down due to quality concerns, can throw a supply chain out of whack and potentially cause a shortage of vital drugs,” he continued. “To ensure we’re prepared to respond appropriately to these issues, we must encourage strong investments to ensure that there are multiple means to develop, store, and distribute drugs.”
Rep. Frank Pallone (D-N.J.), ranking member of the full Energy & Commerce Committee, stressed the need for immediate action. “Experts, including doctors providing care on the front line, told us drug shortages are an ongoing emergency for their patients and a threat to national security,” he said. “Patients and providers are facing life-altering consequences if we don’t do more to address this critical problem.”
In addition to McMorris Rodgers’s bill, the committee was considering several other bills to address the problem, including:
- The Drug Shortage Prevention Act, which would require manufacturers to notify the FDA of a permanent discontinuance or interruption in the manufacture of an excipient (inactive) ingredient or active pharmaceutical ingredient (API) that is likely to result in meaningful disruption in supply. The bill would require the FDA to issue guidance on such notifications no later than 6 months after the enactment of the bill.
- The Ensuring Access to Lifesaving Drugs Act, which would require manufacturers of life-saving drugs to submit expiration and stability testing studies and make labeling changes accordingly; the measure aims to allow manufacturers to extend expiration dates for drugs if it can be done safely.
- The Patient Access to Urgent-Use Pharmacy Compounding Act, which would allow certain facilities to compound drugs when a licensed prescriber certifies to the pharmacist that such prescriber has made reasonable attempts to obtain, but has not been able to obtain, a drug to address an urgent medical need.
Melissa Barber, PhD, postdoctoral fellow at the Yale Collaboration for Regulatory Rigor, Integrity, and Transparency, explained what is generally known about the shortage issue. “First, some types of products, particularly generic style injectables, are in short supply more often than others,” she said. “Second, while any shortage is important to patients, not all shortages are equal in terms of public health importance. Third, we know that markets for some products are highly concentrated. [A] 2023 study found that approximately one-third of generic APIs produced for use in U.S. markets were manufactured by a single facility.”
However, much is not known, she continued. “First, we don’t even know the cause of most shortages that are reported. As of June 2023, 59% of reported shortages in the FDA’s database did not have a declared cause because manufacturers are not obligated to give detailed information, nor does the FDA audit data to ensure accuracy … Second, we don’t know how many manufacturers there are globally for a given drug, where they are, or how much manufacturing capacity they have.”
While there is “no single silver bullet” to fix the problem, “as a first step, the Agency Drug Shortages Task Force previously launched by the FDA should be reconvened as a single point of responsibility,” Barber said. “At the very least, federal agencies can coordinate efforts.”
If the problem isn’t solved soon, the entire generic industry is at risk, said David Gaugh, RPh, interim president and CEO of the Association for Accessible Medicines, which represents generic drug manufacturers. “Unless Congress acts to address these issues today, business practices by middlemen such as group purchasing organizations, wholesalers, pharmacy benefit managers, and health plans are disrupting the economic sustainability of generic manufacturing, shrinking product portfolios, and reducing the availability of resources to counter drug shortages,” he said, noting that nine out of every 10 prescriptions are for generic drugs.
Gaugh recommended that Congress take several steps to mitigate the problem, including exempting low-cost generics from the 340B program and ensuring that Medicare drug plans cover and encourage the use of new generics and biosimilars.
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