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| By David Lim and Lauren Gardner |
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PROGRAMMING NOTE: Prescription Pulse is taking a break on Monday for Memorial Day. We’ll be back in your inboxes on Wednesday, May 29.
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 The FDA has urged health care providers to use syringes not made in China, if possible. | Ted Jackson/AP |
FOCUS ON CHINESE-MADE SYRINGES — Several firms that market Chinese-made plastic syringes in the U.S. are initiating voluntary recalls of the devices. The recalls come amid an uptick in product import alerts from the FDA and after the agency’s latest warning to consumers and health care providers not to use the foreign-made syringes. The FDA announced on Thursday that Medline Industries joined Sol-Millennium Medical and Jiangsu Shenli Medical Production Co. in recalling some of the devices. And four plastic syringe manufacturers in China have been subject to import alerts — a number that may grow, said Suzanne Schwartz, director of the FDA’s Office of Strategic Partnerships and Technology Innovation. She told Prescription Pulse the agency began looking into reports last summer of plastic syringes made in China breaking or leaking. “That has resulted in identifying concerns that appear to be a lot more pervasive, they appear to be more systemic across the manufacturing of these plastic syringes that are coming in from China,” Schwartz said. Reports on problems with medical devices are voluntary — meaning the FDA may not be aware of adverse events when they occur. To date, the issues don’t seem to be tied to any patient deaths. The problems “relate primarily to malfunction in the performance of the device as opposed to any patients being injured or hurt,” Schwartz said. “We are not aware of patients actually sustaining injuries.” What else: The White House recently announced tariffs on Chinese-made syringes and needles, and other devices, including personal protective equipment. The tariffs are aimed at encouraging domestic manufacturing of products by boosting U.S. syringe maker cost competitiveness. “Well, obviously tariffs are outside of our purview, but I certainly appreciate the administration trying to take efforts to ensure the domestic supply chain of syringes and select personal protective equipment,” Jeff Shuren, the FDA’s top medical device regulator, said. Schwartz said the agency is keeping a “very close eye” on the syringe supply chain because of how important the devices are for patient care. “We have not to date received any signals of concern with regard to unavailable, lack of available devices,” Schwartz said. “But we are going to continue to monitor for that.” IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. We can’t say we’re enjoying the return of humidity to the DMV. Send news and tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).
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A SECOND CASE — Hours before public health officials on Wednesday announced the second case of human avian flu in this year’s outbreak among cattle, Peter Marks, the FDA’s top vaccine regulator, spoke to Congress about the agency’s vaccine plans. If necessary, Marks said, the agency could use supplements to existing approved avian flu vaccines or emergency-use authorization to quickly deploy human avian flu vaccines. The second confirmed infection occurred in a Michigan farmworker exposed to livestock with avian influenza, and the person has recovered from mild eye symptoms. CDC officials said it’s notable that a nasal swab of the person tested negative for conventional flu, while an eye swab the agency received on Tuesday tested positive for avian flu. Federal officials said they still believe the risk to the public is low and that increased surveillance, especially of workers in the dairy industry, will be closely monitored.
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CAVAZZONI, MARKS, SHUREN TAKE THE HILL — The top FDA regulators of drugs, biologics and medical devices made their annual pilgrimage to Capitol Hill Wednesday, where they weathered a bipartisan barrage of questions from lawmakers on a number of pet issues. Drug shortages: House Energy and Commerce ranking member Frank Pallone (D-N.J.) and other lawmakers lamented that bipartisan legislation to address the persistent issue has not materialized. “We’re also quite worried,” top FDA drug regulator Patrizia Cavazzoni told members of the House Energy and Commerce Health Subcommittee. “We are also very, very interested in having more transparency on where drugs are made and particularly how much of a drug is made in a specific location.” LDT drama: Multiple lawmakers on both sides of the aisle expressed concern about the FDA’s recent final rule on the regulation of laboratory-developed tests. Rep. Diana DeGette (D-Colo.) said she and Rep. Larry Bucshon (R-Ind.) — sponsors of a bill that would overhaul how diagnostics and lab tests are regulated — are meeting with the chairs and ranking members of the House Energy and Commerce Committee and the Senate HELP Committee about getting that legislation over the finish line this year. “There’s general opposition to the FDA rule as being a blunt instrument,” DeGette said. “It’s taken some time for some of the stakeholders to realize [the new rule] is going to be the law unless we pass the VALID Act.” Shuren told reporters the FDA is open to working with Congress on the proposed bill. White Oak campus: Several Republicans pressed agency leaders again about returning more FDA staffers to in-office work. Cavazzoni noted the FDA said last week that advisory committee meetings will be held in-person going forward. The closely watched meetings of independent experts reviewing drug and device approval applications went virtual during the pandemic.
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 Senate Majority Leader Chuck Schumer said more actions will follow the vote on legislation that would create a federal right to contraception. | Francis Chung/POLITICO |
CONTRACEPTION IN FOCUS — Senate Majority Leader Chuck Schumer said this week he will hold a vote next month on legislation establishing a federal right to contraception amid concerns presumptive GOP presidential nominee Donald Trump could restrict access if he wins in November. Schumer’s plans coincide with the two-year anniversary of the Supreme Court overturning Roe v. Wade, which was a nearly 50-year-old high court precedent confirming federal abortion rights “There will be more action to come after that,” Schumer said Thursday on the Senate floor. “At a time when tens of millions of women are worried about reproductive health — although many male Americans are worried as well — Senate Democrats will focus on protecting fundamental freedoms like the right to choose, access to IVF, continued access to contraception and more.”
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LOUISIANA TIGHTENS ABORTION PILL PENALTIES — Louisiana became the first state Thursday to pass legislation making the pills used in medication abortions controlled substances, Megan writes. If the GOP governor signs the bill into law, as expected, state residents who possess the pills without a prescription would face criminal penalties, such as jail or a hefty fine. Pregnant women who obtain the medications for their own use would be shielded from criminal liability. But anyone who helps them get the pills — and non-pregnant women who obtain them as a precaution — could face criminal penalties.
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| OUD CAMPAIGN LAUNCHED — The FDA kick-started an effort Thursday to promote resources to help primary care providers identify and treat opioid use disorder, or OUD. The new campaign focuses on medications like buprenorphine that help curb opioid cravings. Clinicians no longer need to obtain so-called X-waivers to prescribe the drug, and a DEA official said last month the total volume of prescriptions for the drug didn’t rise as much as expected since the waiver mandate was lifted. “Treatment of OUD, including with medications, can save lives, and so can the clinicians who prescribe them,” FDA Commissioner Robert Califf said in a video posted to X.
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Stacey Frisk is joining the Rare Disease Company Coalition as executive director. She joins the group from rare disease drugmaker Sarepta Therapeutics.
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