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| By Lauren Gardner and Katherine Ellen Foley |
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The FDA needs to plan how it can hire staff with expertise in cosmetics or chemicals to ensure product safety, says the GAO. | Mark Lennihan/AP |
GAO: FDA NEEDS BETTER COSMETICS PLANNING — A government watchdog is calling on the FDA to come up with additional plans to implement new powers and bolster staffing for cosmetics safety. “FDA has taken important steps, such as designating leadership and engaging its employees, to implement the new cosmetics law, but its actions do not fully address leading practices for agency reform,” such as organizational changes, the Government Accountability Office said in a new report this week. FDA Chief Scientist Namandjé Bumpus told the GAO that the agency uses the 2022 law granting the cosmetics authority as a “roadmap” for implementation and it hasn’t fully tackled strategic workforce planning because officials are focused on complying with the statute’s near-term requirements. Under the law, companies must register their manufacturing facilities and products by the end of the year, though the agency has already punted enforcement of those requirements for six months. The FDA must also propose rules that set and mandate standardized testing methods for detecting asbestos in talc-containing products by Dec. 29. The GAO acknowledged the logic of prioritizing the law’s early deadlines, but the watchdog warned that the lack of interim planning could hurt the agency’s ability to meet requirements outlined in the law through 2025. The FDA needs a plan to recruit personnel with expertise in cosmetics or chemicals as it waits for Congress to appropriate funding for implementation, the GAO said. The FDA generally agreed with the GAO’s recommendations, which also included reporting on implementation milestones and evaluating how that work affects the agency’s current and future workforce. Noteworthy: The agency’s working group on cosmetics implementation includes the deputy director of the Office of the Chief Scientist and the director and deputy director of the Office of Cosmetics and Colors, which GAO said “provides for leadership succession” if Bumpus or Linda Katz, director of the Office of Cosmetics and Colors, were to leave. An FDA spokesperson said Bumpus’ leadership role on cosmetics implementation “will not be impacted” when she becomes the agency’s principal deputy commissioner next year. IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. Today is Katherine’s last day at POLITICO — we’ll miss her but know she’ll knock her next endeavor out of the park! Send news and tips to Lauren Gardner (lgardner@politico.com or @Gardner_LM) or David Lim (mailto: dlim@politico.com or @davidalim). TODAY ON OUR PULSE CHECK PODCAST, your host Katherine talks with POLITICO White House Correspondent Adam Cancryn, who explains why the White House says it can use "march-in rights" to seize patents for certain drugs partly developed with federal funds and how the move could give the president another tool in his effort to lower drug prices.
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Advocates want to expand the number of suncreens for sale in the U.S. | Mary Godleski/AP |
SPF WATCH — Public health and industry advocates on Thursday said the FDA should allow more sunscreens on the U.S. market and should work with companies to vet data supporting existing ingredients’ safety and effectiveness. The event on Capitol Hill, organized by skin cancer survivor Rep. Dave Joyce (R-Ohio), comes months after Rep. Alexandria Ocasio-Cortez (D-N.Y.) suggested more should be done to get different sunscreen filters permitted in the U.S., like those approved in Europe and Asia. “Darker skin types don’t find the sunscreens that leave a chalky residue cosmetically acceptable,” Dr. Maral Skelsey of the American Society for Dermatologic Surgery said. The best sunscreen option, health advocates say, is a product someone will choose to use every time they’re exposed to sunlight. Regulatory status: The FDA has proposed just two active ingredients — zinc oxide and titanium dioxide — as generally recognized as safe and effective, a standard known as GRASE. It has proposed to take two ingredients off the market and consider 12 others not passing the GRASE standard due to insufficient data. And the agency has yet to act on several other new filters for which companies have sought FDA approval. Industry and skin cancer prevention advocates say regulators should consider standards used internationally to evaluate sunscreen ingredients. Other countries regulate sunscreen as a cosmetic, but the FDA treats it as an over-the-counter drug due to product claims about sunburn and skin cancer prevention.
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MENTHOL BAN DELAYED — Public health groups are frustrated that the FDA’s anticipated ban on menthol cigarettes has been pushed to March or possibly later. “This delay not only puts the rules at risk of never being finalized but also represents a significant victory for Big Tobacco’s well-documented exploitative practices, all at the expense of our nation’s public health,” Kathy Crosby, president and CEO of the anti-smoking group Truth Initiative, said in a statement. The Office of Management and Budget has held a slew of meetings with leaders from the tobacco and convenience store industries, law enforcement groups and public health leaders in recent weeks regarding the pending rule. The ban, initially targeted for August, would have been one of the largest actions the FDA had taken to date to curb smoking.
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WHO WARNS OF CONTAMINATED SYRUPS — The World Health Organization issued a medical product alert for five types of allergy, cough and digestional liquid medication that could contain dangerous contaminants known as diethylene glycol and ethylene glycol. Medical product authorities in the Maldives, Australia and Pakistan identified the chemicals in the products, made by the Pakistani company Pharmix Laboratories, last month. The Drug Regulatory Authority of Pakistan ordered Pharmix to stop making all liquid medicines after a manufacturing inspection found the chemicals might be present in other product batches The FDA has kept a keen eye out for those contaminants, and so far, none has been found in the U.S. Earlier this year, the agency finalized guidance documents for the medical product industry, dictating ways for manufacturers to test for the chemicals plus other harmful contaminants. In August, it issued warning letters to companies that failed to show that they tested their products to prove they were free of the chemicals.
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ISSUES WITH CAR-T MANUFACTURING? The FDA published a letter it sent this week to Novartis regarding the manufacturing of its cancer immunotherapy treatment Kymriah. The letter, which dates to August, details several concerns agency inspectors noted about Kymriah’s manufacturing plant in Morris Plains, N.J., in late 2022. Novartis initially responded to some of the problems inspectors found. The August letter discloses additional shortcomings, including Novartis’ failure to establish controls that would guarantee batches of Kymriah are free from particulate matter and biological contaminants like mold. Kymriah was the first chimeric antigen receptor T-cell, or CAR-T, therapy to receive FDA approval in 2017. Novartis did not respond to Prescription Pulse for comment. The agency said last week it plans to investigate whether six CAR-T therapies, including Kymriah, could lead to the development of blood cancers. Eyes emoji: The FDA is also slated to make a decision on the first gene-editing therapy today.
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| JOIN WOMEN RULE ON 12/12: For centuries, women were left out of the rooms that shaped policy, built companies and led countries. Now, society needs the creativity and entrepreneurship of women more than ever. How can we make sure that women are given the space and opportunity to shape the world’s future for the better? Join POLITICO's Women Rule on Dec. 12 for Leading with Purpose: How Women Are Reinventing the World to explore this and more. REGISTER HERE. |
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| Reynolds American has named Borgia Walker as the company’s senior vice president of Human Resources and Inclusion. She was previously the company’s vice president of human resource services and integration.
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Pfizer has decided to leave the Biotechnology Innovation Organization, Rachel Cohrs reports for STAT. The FDA has cleared the first at-home artificial insemination kit, Mary Walrath-Holdridge reports for USA Today.
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| A message from CVS Health: Whether in the community, at home or virtually, consumers want health care that is convenient, personalized and affordable. And we’re delivering. By connecting each step of your care – from a medical appointment to a trip to the pharmacy to ongoing check-ins with your care team – we’re making healthier happen together.
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HHS’ Office of the Assistant Secretary for Planning and Evaluation published a report Thursday that found that less competition for prescription drugs led to higher prices. The FDA published interim guidance documents on Thursday on compounding bulk drug ingredients. Sixteen health organizations led by the National Hispanic Medical Association wrote to FDA Commissioner Robert Califf this week, urging the agency to expedite the approval of new Covid-19 treatments. |
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