June 15, 2023
There's an acute shortage of injectable cancer drugs because manufacturers can't make money off of them, two experts told a U.S. House subcommittee Tuesday. But it's unclear whether chaos in the GOP Caucus that's supposed to be running the chamber will allow for action.
The testimony came before the Health Subcommittee of the House Energy and Commerce Committee. A subject of the hearing was to consider reauthorization of the Pandemic and All Hazards Preparedness Act, or PAHPA. It was passed in 2006 amid a threat of an Avian Influenza pandemic that didn't materialize, but was used heavily during the coronavirus pandemic 14 years later.
Democratic members of the subcommittee have delayed support for the reauthorization as they push for broader reforms to the drug supply chain. But U.S. Rep. Richard Hudson, R-N.C., said the dynamics of the House Republican Caucus made passage of such ambitious legislation unlikely.
"I'm afraid that my colleagues are losing sight of the fact that we need to pass this bill this year," he said. "From the beginning, I've worked with the Democrats to negotiate a bill that can pass the House — particularly considering the dynamics of this current Congress. I've been clear since the start about my priorities and the confines we're working under."
That likely was a reference to a small group of hard-right Republicans who only grudgingly voted to make Rep. Kevin McCarthy, R-Calif., speaker. Last week they blocked all legislative activity on the House floor out of anger over a deal McCarthy made with President Joe Biden to save the nation from defaulting on its debt and throwing global financial markets into chaos. On Monday, the lawmakers said they would temporarily suspend their blockade, The Hill reported.
In response to Hudson, Rep. Frank Pallone, D-N.J., on Tuesday said Congress shouldn't allow a small group of radicals to dominate the legislative process.
"I'm sorry, but the Republican disarray on the floor should not be the basis not to act," Pallone said of broad drug reforms. "Because I don't know on any given day… We had four days without voting on anything. So what does that mean? Am I supposed to not introduce bills or try to act on anything because some people on the right are going to take down the speaker? We can't act on that. We can't proceed based on that. And PAHPA is a must-pass bill, so if we don't include legislation addressing drug shortages now, it's just not going to happen."
Two experts told the panel that the shortage of certain injectable generic cancer drugs is acute and getting worse.
"Today's shortages are the worst I have seen in my 30-year career," Julie R. Gralow, Chief Medical Officer & Executive Vice President of the Association for Clinical Oncology, said in written testimony. "In 2022, approximately 100,000 Americans were diagnosed with ovarian, bladder and testicular cancers, cancers which may rely on cisplatin or carboplatin for treatment. These 100,000 patients may not have access to lifesaving treatment."
Gralow said the drugs can also be used to treat cervical, endometrial, lung, head and neck, bladder, esophageal, gastric, breast and more cancers. She added that as many as half a million Americans might be affected by their shortages each year.
"From 2010 to 2020, eight of the 10 most frequently used drugs to treat acute lymphoblastic leukemia — the most common childhood cancer — were at some point temporarily unavailable," Gralow said.
Ted Okon, executive director of the Community Oncology Alliance, put the problem even more starkly.
"There is a growing crisis of a severe shortage of low-cost generic drugs used to treat cancer including carboplatin, cisplatin and fluorouracil," he said. "Although decades old, these are mainstays for many types of cancers — including curable cancers. As a result of these drug shortages Americans with cancer are facing treatment delays, potentially receiving inferior treatments and even having their treatment stopped."
Okon added, "What is heartbreaking is that Americans with potentially curable cancers may miss treatments or even a cure because of these shortages. Our inaction in fundamentally solving the cancer-drug shortage problem — which has existed for years, but is now as severe as we've ever faced — has likely signed a death sentence for Americans."
Okon said that well-intentioned programs capping generic prices and requiring manufacturer discounts are band aids that are actually making the shortage of injectable generic cancer drugs worse.
"The fundamental, root cause of cancer drug shortages is financial," he said. "Unfortunately, recent solutions deal with symptoms of the problem, but none address the underlying financial causes. If a generic drug manufacturer cannot make a profit off a drug, it will simply stop making the drug."
Lives literally depend on Congress taking action, Okon said.
"Congress needs to stop band-aiding the problem and fix the fundamental financial problem, as well as bring manufacturing back to the United States," he said.
This story was first published by the Ohio Capital-Journal, a sibling site of the Pennsylvania Capital-Star.
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