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Tuesday, July 23rd, 2024

Capitol Hill lawmakers vow to end U.S. drug shortages, dependency on Chinese pharma 

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The rising dependence that the United States has on many Chinese pharmaceuticals is worsening the nation’s drug shortage and creating a national security risk that several members of Congress want to disrupt.

Lawmakers, in fact, have introduced legislation in Congress from both sides of the aisle that offer proposed policy solutions to advance the manufacturing of American-made drugs, while others are calling on the Biden administration to explain why the nation still relies so heavily on Chinese-manufactured drugs or their components.

“Right now, many, many communities across our country are facing a huge shortage of children’s pain killers, like Children’s Tylenol, antibiotics, and amoxicillin,” U.S. Sen. Tommy Tuberville (R-AL) said on the floor of the U.S. Senate. “My staff is hearing from folks daily about the problems that they’re seeing trying to find these medicines — both over-the-counter and prescription.”

“We need to produce pharmaceuticals in the United States,” he added. “The United States has every capability to produce essential goods right here at home.”

Echoing that call is U.S. Rep. Cathy McMorris Rodgers (R-WA), chair of the U.S. House Energy and Commerce Committee, who is leading an investigation into the nation’s ongoing drug shortages and the Food and Drug Administration’s (FDA) response to the issue.

“In recent years, there have been shortages of critical medications such as antibiotics, flu therapeutics, saline, morphine, and cancer drugs,” the congresswoman wrote in a March 27 letter sent to FDA Commissioner Dr. Robert Califf. “In fact, new drug shortages in the country saw a 30 percent increase from 2021 to 2022, posing a risk to public health and national security.”

U.S. Reps. Brett Guthrie (R-KY) and Morgan Griffith (R-VA), who also sit on the Energy and Commerce Committee, joined Rodgers in signing the letter, which noted that the FDA Drug Shortage Database lists over 120 drugs that are currently in shortage, while a drug shortage list from the American Society of Health System Pharmacists includes more than 233 such entries.

The members acknowledged that the FDA monitors ongoing drug shortages and works closely with manufacturers and others in the supply chain to understand, mitigate and prevent or reduce any related impacts, and that the agency has also requested additional legal authority from Congress to gain additional access to medical supply chain information.

But, they say it isn’t clear to their committee that the FDA “is effectively using its existing authorities.”

“To date, the FDA has not publicly released any summary of these reports in an aggregated way that may inform policy makers and provide the data Congress and others need as we examine ways to make sure the supply chain for drugs Americans need is secure,” they wrote.

The lawmakers requested that Dr. Califf answer numerous questions by April 13, including the total aggregated amount of each listed drug reported for each of calendar years 2020 through 2022, and to identify several details, including the country of origin engaged in the manufacturing and processing of the drug, and whether the drug is approved under the Federal Food Drug and Cosmetic Act.

Among other questions, they also want to know how information is being used to inform foreign inspection priorities and mitigate potential drug shortages, and requested information regarding the shortages of several drugs, including albuterol, amoxicillin, acetaminophen, and ibuprofen, according to their letter.

In fact, shortages of drugs like children’s medications and antibiotics increased by almost 30 percent between 2021 and 2022, according to a report released last month by Democrats on the U.S. Senate Homeland Security and Governmental Affairs Committee.

“Shortages of critical medications continue to rise — including drugs used in hospital emergency rooms and to treat cancer, prescription medications, and even common over-the-counter treatments like children’s cold and flu medicine,” according to the report, “Short Supply: The Health and National Security Risks of Drug Shortages,” which noted that the number of active drug shortages in the U.S. reached a peak of 295 at the end of 2022.

“Both the pharmaceutical industry and the federal government, including the [FDA], lack the information needed to effectively detect and prevent shortages,” said U.S. Sen. Gary Peters (D-MI), who chairs the committee. “Most significantly, this updated report found that our continued overreliance on foreign suppliers for the key materials needed to make critical drugs, primarily those in China, remains an unacceptable national security risk.”

The report found that drug shortages in America are also on the rise due to economic drivers, insufficient visibility into supply chains, and increased demand, all of which have made it harder for healthcare professionals to treat patients.

“While some shortages may only be an inconvenience, others can have devastating impacts on patient care,” Peters said during the March 22 committee hearing held to examine the ongoing and rising shortages of medications. “Taken together, these underlying causes not only present serious concerns about providing adequate care to patients, they also represent serious national security risks.”

Recommendations in the March report include that the federal government invest in advanced manufacturing capabilities to produce critical drugs in the U.S., and that Congress requires the FDA and its interagency partners to get the information needed to better monitor supply chain vulnerabilities and anticipate possible shortages.

Citing similar concerns, several House members on March 28 launched the bipartisan Domestic Pharmaceutical Manufacturing Caucus for the 118th Congress.

U.S. Reps. Buddy Carter (R-GA), Elissa Slotkin (D-MI), Chrissy Houlahan (D-PA), and Gus Bilirakis (R-FL) are co-chairs of the new caucus, which they say will focus on advancing legislation that incentivizes more domestic production for essential medicines in an effort to reduce American reliance on foreign adversaries, head off potential supply chain disruptions, and ensure a steady supply of pharmaceuticals in the event of public health emergencies or natural disasters.

“When your life depends on access to a prescription drug, you do not want to rely on the Chinese Communist Party to deliver those medications,” said Carter, who also serves on the Energy and Commerce Committee.

“Unfortunately, our pharmaceutical industry has been shipped overseas, at the expense of patients,” he added. “The Domestic Pharmaceutical Manufacturing Caucus will provide supply chain security for every American and is another step towards re-shoring this important industry.”

Slotkin also said that if the COVID-19 pandemic has taught the U.S. anything, it’s that the nation can no longer be dependent on others for critical supplies like prescription drugs.

“There’s a bunch of members of Congress, across the political spectrum, who have learned those hard COVID lessons and are hellbent on ensuring we don’t leave ourselves vulnerable again,” said Slotkin.

Pending legislation

Congressional lawmakers have also proposed bills with the same goal to reduce U.S. reliance on foreign drugs.

Most recently, U.S. Sens. Marco Rubio (R-FL) and Elizabeth Warren (D-MA) on March 29 introduced S. 1057, a bipartisan bill that would codify recommendations from a September 2021 U.S. Department of Defense (DOD) Office of Inspector General (OIG) report addressing the department’s pharmaceutical supply chain weaknesses.

The senators have said that DOD’s medical and pharmaceutical supply chain has a unique set of concerns and vulnerabilities that, if left unaddressed, represent a serious risk to national security. And they’ve urged the Biden administration to prioritize the challenges to DOD and the national security risks posed by overreliance on pharmaceuticals produced abroad.

Specifically, their bill includes the DOD OIG recommendation that instructions used by the Defense Logistics Agency (DLA) be modified to require DLA Troop Support to coordinate annually with military service customers to conduct responsiveness testing of the DLA’s contingency contracts for pharmaceuticals, and to include the testing results in the Warstopper Program annual reports.

“The report from the DOD OIG only confirms what was made glaringly obvious during the COVID-19 pandemic: the United States remains dangerously reliant on foreign nations for its pharmaceuticals,” Rubio said. “It is unacceptable that we do not currently have a plan in place to address these supply chain issues.”

Rubio and Warren say that DOD must consider pharmaceuticals in its work to shore up vulnerable supply chains important to national security just as it does for semiconductors, microelectronics, and rare earth minerals.

Rubio in January also sponsored the bicameral Medical Manufacturing, Economic Development, and Sustainability (MMEDS) Act of 2023, S. 33/H.R. 447, which would provide incentives for relocating medical manufacturing facilities in the United States, including Puerto Rico, and for manufacturing medical products like drugs and devices in economically distressed zones. U.S. Rep. Jenniffer González-Colón (R-PR) sponsored the House version of the bill.

“We cannot be a strong nation if we are dependent on hostile foreign regimes for basic goods, medicines, and critical technologies,” Rubio said. “There is growing bipartisan support to prioritize rebuilding our critical industries. Doing so will strengthen our nation’s supply chains and bring good jobs back to America.”

Also in January, Congressman Carter joined U.S. Rep. Lisa Blunt Rochester (D-DE) to unveil the bipartisan Essential Medicines Strategic Stockpile Act of 2023, H.R. 405, which would amend the Public Health Service Act to provide for stockpiles that ensure all Americans have access to generic drugs at risk of shortage.

Specifically, H.R. 405, which is under consideration in the House Energy and Commerce Committee, would require the U.S. Department of Health and Human Services to establish a list of 50 generic medications that are essential in public health emergencies, the same way the U.S. has a reserve of oil for energy-related emergencies.

“COVID-19 made it abundantly clear that the United States cannot rely on China for the safety and security of our drug supply chain,” Carter said. “When a parent goes to the store and sees an empty shelf where amoxicillin should be, the emergency stockpile of essential medicines is no longer an idea, it’s a life-saving measure.”

During his floor speech, Tuberville also pointed out that America is long overdue for a change in its approach.

“If Congress does not act to restore America’s medical and pharmaceutical industries, it will show… a willful negligence of potentially deadly proportions,” he said.