|
Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | |  | | By David Lim, Lauren Gardner and Katherine Ellen Foley | | | | | 
The FDA says a drop in notifications of medical device shortages might be attributed to device makers no longer voluntarily reporting them. | AP Photo | AP Photo | DEVICE SHORTAGE REPORTING NOSEDIVES — Without any help from Congress expected in the near term and an industry resistant to shortage reporting requirements, the FDA’s top medical device regulator says data bolsters the agency’s worry that medical device companies are not voluntarily reporting shortages after a legal requirement tied to the Covid-19 public health emergency lapsed in May. “Without requiring device shortage notifications outside of a PHE, our device supply chain and U.S. public health remain at risk,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, told POLITICO. “Due to the decrease in notifications, we may not be receiving information essential to prevent or mitigate critical medical device shortages.” During the final months of mandatory reporting in April and May, the agency received more than 30 notifications of new shortages, updates to existing shortages and shortage close-outs. In June, when the alerts were voluntary, the agency received three updates to existing shortages. In July, the agency was notified of only one new shortage. Congress is not poised to include an expansion of device shortage reporting requirements: Both the House Energy and Commerce Committee and the Senate Committee on Health, Education, Labor and Pensions advanced pandemic preparedness bills that do not include such a provision. Scott Whitaker, CEO of the device industry trade group AdvaMed, argued companies voluntarily report shortages “that might require FDA’s help to alleviate” but said many “short-term bottlenecks” should not have to be reported. The medical device industry has opposed a broad extension of shortage reporting requirements over concerns about compliance burden, even though the FDA has long sought congressional authority to mandate reporting requirements outside of public health emergencies. IT'S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. We hope everyone is safe after yesterday’s mid-Atlantic storms. Send news and tips to David Lim (dlim@politico.com or @davidalim), Lauren Gardner (lgardner@politico.com or @Gardner_LM) and Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). TODAY ON OUR PULSE CHECK PODCAST, host Ben Leonard talks with Alice Miranda Ollstein, who describes the challenges facing Reps. Brad Wenstrup (R-Ohio) and Raul Ruiz (D-Calif.) as chair and ranking member of the committee investigating the government response to Covid-19 — and how their inability to find common ground on the pandemic response threatens their 10-year bipartisan collaboration and friendship while raising concerns about further erosion of public trust in government.
| | | | | | | 
As a result of several people contracting tuberculosis after they were treated with bone graft materials, donor requirements in the U.S. have been tightened. | AP Photo/Lefteris Pitarakis | UPDATED TISSUE SCREENING GUIDANCE — The American Association of Tissue Banks updated its donor screening requirements Monday for member companies amid a tuberculosis outbreak suspected to be linked to bone graft materials. There is no approved lab test for detecting tuberculosis in donor cadavers, making screening of prospective donors integral to preventing the bacterium’s spread via bone and tissue products used in medical procedures. Potential donors with a history of TB or a latent infection diagnosed within the past two years are ineligible to donate tissues, AATB said. Individuals who were exposed to someone with TB within the past two years, tested positive for TB more than two years ago, were on dialysis for chronic renal failure, received a solid organ transplant or are older than 65 are ineligible to donate tissues containing viable cells that can be turned into products processed to retain live cells. State update: Of the 36 patients the CDC has identified as having had a surgical or dental procedure using the suspected contaminated products, nine received them in Texas, five in Louisiana, two in Michigan and one in New York City, state health officials told Lauren and our Alice Miranda Ollstein. Other states didn’t respond to inquiries or declined to disclose patient numbers. Seven of the Texas patients have been offered prophylactic TB treatment while awaiting test results, Department of State Health Services spokesperson Lara Anton said, and the state is investigating whether others were exposed. The two other patients are New Mexico residents; the state’s health department said they’re receiving treatment. Both Michigan patients have been diagnosed with TB and are receiving treatment, state Department of Health and Human Services spokesperson Lynn Sutfin said. Two household contacts of one patient have tested negative and will be retested in about two months, she said.
| | | | YOUR TICKET INSIDE THE GOLDEN STATE POLITICAL ARENA: California Playbook delivers the latest intel, buzzy scoops and exclusive coverage from Sacramento and Los Angeles to Silicon Valley and across the state. Don't miss out on the daily must-read for political aficionados and professionals with an outsized interest in California politics, policy and power. Subscribe today. | | | | | | | | | WHERE IS THE NOVAVAX XBB.1.5 SHOT? — The manufacturer of the only available protein-based Covid-19 vaccine will report its second-quarter earnings this morning. Novavax’s vaccine is based on the spike protein of the original SARS-CoV-2 virus, and the company has said previously that it is prepared to supply the updated monovalent shot that can provide immunity against the widely circulating XBB.1.5 Omicron subvariant this fall. But Novavax has yet to seek FDA authorization for its updated shot. The agency is already considering updated immunizations from Pfizer-BioNTech and Moderna, which submitted applications for their mRNA shots in June. According to guidance documents from the CDC published in July, the FDA is expected to make authorization decisions on those shots in mid-to-late September. “It could be that Novavax is bowing out of the Covid vaccine game” because the shot’s uptake has been so limited, said a former FDA official not authorized to speak about the company’s plans. As of Monday, fewer than 90,000 of Novavax’s shots had been administered, compared with hundreds of millions of mRNA immunizations. But the FDA may not need a large lead time to evaluate XBB.1.5 shots. Last year, there was only about a week between when Pfizer-BioNTech and Moderna asked the agency to authorize their Omicron booster and when the agency gave the shots the green light.
| | UNDERUSE OF OPIOID DISORDER DRUGS — Federal researchers found that only 20 percent of Americans with opioid use disorder received medications to treat the condition in 2021 and that telehealth was linked to an increased likelihood that patients were given prescriptions. The report by NIH and CDC researchers also found that groups less likely to be prescribed medications like buprenorphine, methadone and naltrexone included Black adults, women, the unemployed and people who lived outside of metropolitan areas. About 107,000 people died of drug overdoses in the U.S. in 2021, and 75 percent of the overdoses involved an opioid. The researchers want more data on whether a 2023 law that eliminated a requirement for providers to obtain a waiver to prescribe buprenorphine helped boost treatment.
| | Families USA has named Tasha Dawson director of strategic partnerships. She was previously manager of outreach and partnership engagement at the HHS Office of Minority Health Resource Center. The Indian Pharmaceutical Alliance, an international association representing India’s drugmakers, hired former generic industry group leader Kathleen Jaeger to help it increase collaboration with U.S. pharma regulators, Megan R. Wilson reports.
| | The EU’s e-cigarette regulations have led to a massive number of adult smokers switching to vapes — but they also led to an uptick in youth vaping, POLITICO’s Ashleigh Furlong reports. For The New Yorker, Dr. Sunita Puri details how CPR rose to medical fame, despite its brutality and high failure rate. Sage Therapeutics could face job and pipeline cuts after the FDA approved Zurzuvae as the first pill to treat postpartum depression — but not for major depressive disorder, Ryan Cross reports for Endpoints News.
| | The FDA issued draft guidance Monday for cosmetics manufacturers that must comply later this year with new facility and product-registration guidelines. The FDA seeks cosmetic industry participants for a pilot program to evaluate a potential electronic portal for product facility registration and listing.
| | | | HITTING YOUR INBOX AUGUST 14—CALIFORNIA CLIMATE: Climate change isn’t just about the weather. It's also about how we do business and create new policies, especially in California. So we have something cool for you: A brand-new California Climate newsletter. It's not just climate or science chat, it's your daily cheat sheet to understanding how the legislative landscape around climate change is shaking up industries across the Golden State. Cut through the jargon and get the latest developments in California as lawmakers and industry leaders adapt to the changing climate. Subscribe now to California Climate to keep up with the changes. | | | | | | | | | Follow us on Twitter | | | | Follow us | | | | |  |
