Deliberations began this with week on the U.S. Senate’s version (S. 3187) of the Prescription Drug User Fee Act (PDUFA), which includes provisions to help mitigate potential shortages of lifesaving drugs, but the American Society of Hematology wants to know why the bill exempts certain classes of drugs from its proposed mandatory early warning system.
ASH President Armand Keating, MD, told me that the bipartisan legislative effort is a great start but does not go far enough since it exempts biologics and plasma products, which will not be part of the governmental safety net ensuring that manufacturers notify the Food and Drug Administration about potential shortages of drugs that are life-supporting or life-sustaining, or used to prevent debilitating diseases or conditions.
He said that the House version (HR 5651) slated for discussion next week does not have the biologics exclusion, but does exclude plasma protein products used to treat hemophilia and other serious bleeding disorders, which have had a history of shortages.
“It [the legislative effort] is really preliminary and doesn’t deal with all the issues," Keating said.
"There are a disproportionate number of products that have experienced shortages that are off patent and injectable, sterile, and in some cases not replaceable. We should not have to put our patients in the position of having their care compromised,” he said, adding that he wondered if similar shortages occur “for those products that still have robust intellectual property protection.”
According to ASH, a manufacturer went to Capitol Hill and said that the plasma protein industry already had a reporting system in place and did not need the new requirement.
However, that system was voluntary and tracked the production rather than shortages of only five of 25 products on the market.
Keating also said that another limitation of the bill was the lack of a penalty for failing to report shortages, and that ASH recommends including an enforcement mechanism that instructs the Secretary of Health and Human Services to establish regulations for civil monetary penalties.
I called the American Society of Clinical Oncology regarding its views on the legislation and received this response via email from ASCO President Michael P. Link, MD: “We are also pleased that the prescription drug user fee legislation currently being debated in the Senate requires manufacturers to give the FDA six-months’ notice of an anticipated shortage of a lifesaving therapy. However, fines or some other type of enforcement mechanism are needed to ensure manufacturers comply with this requirement. ASCO hopes that this change may be added before final passage.
"The bill also allows for the inclusion of biologics if the HHS Secretary determines that it would be for the benefit of public health," Link continued. "Biologics are already first-line treatments for numerous cancers and will become more critical components to care as their use in the U.S. becomes more prevalent. If this legislation becomes law, we would urge the Secretary to include biologics and biosimilars to fully protect cancer patients.”
OT will monitor Congressional action on the bill and its final outcome.
Today, the Senate passed S. 3187, its version of the Prescription Drug User Fee Act (PDUFA).
The House of Representatives is expected to vote on its version, HR 5651, next week.
The House of Representatives passed its version (HR 5651) of the Prescription Drug User Fee Act (PDUFA) yesterday, but the American Society of Hematology says that it remains concerned that the legislation still exempts products derived from human plasma protein derivatives and recombinant products replacing human tissue used in treating hemophilia and other blood disorders. However, the House bill does include biologics that were exempt from the Senate's bill.
Both the House and Senate versions will go to committee to reconcile differences before being sent to the president.