| | | | |  | | By Lauren Gardner and David Lim | Presented by the Coalition for Affordable Prescription Drugs (CAPD) | With Katherine Ellen Foley, Megan Wilson and Alice Miranda Ollstein Programming note: We won't be publishing Prescription Pulse Tuesday because of Presidents Day. Instead, we'll be in your inboxes on Wednesday.
| | | — An independent federal agency hit an impasse on whether to launch a study of pharmacy "middlemen." — FDA sets an advisory meeting to discuss an ALS drug candidate, despite asking for more data last year. — Robert Califf was sworn in as FDA commissioner once again Thursday. It's Friday. Welcome back to Prescription Pulse. There's a new FDA sheriff in town, complete with his own brand-new Twitter handle — a development one former commissioner enthusiastically endorses. Send tips, feedback and Twitter love to David Lim (dlim@politico.com or @davidalim), Lauren Gardner ( lgardner@politico.com or @Gardner_LM) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley).
| | A message from the Coalition for Affordable Prescription Drugs (CAPD): New polling shows that Americans aren't fooled by Big Pharma. Voters clearly know that big drug companies are responsible for high drug prices. More than that, they want Congress and the Administration to take immediate action to protect patients by addressing the problem at its root: the high and rising prices set by Big Pharma. Learn more. | | | | | | FTC PUNTS ON PBM PROBE — The Federal Trade Commission deadlocked along party lines Thursday on whether to launch a study of the U.S.' biggest pharmacy benefit managers , POLITICO's Leah Nylen and Megan Wilson report. Republican commissioners voted against a study because, as drafted, it wouldn't consider concerns such as the impact of PBMs on out-of-pocket costs for consumers. The Republicans indicated they want to work with Chair Lina Khan to approve a study. "I see this as an area where we have a real moral imperative as an agency to act," she said, calling the issue a "life-or-death" situation. The commission heard from more than 20 members of the public, including two Republican lawmakers and a slew of pharmacists and pharmacy groups — all of whom wanted the agency to crack down on the pharmacy middlemen. Voting for the probe wouldn't have launched a law enforcement action; instead, it would have approved the development of a study from which information could be used to open investigations into certain companies. The largest players in the PBM space — CVS Caremark, Express Scripts and OptumRX — represent nearly 80 percent of the market and are either owned by or own insurance companies. The trio also represents three of the four largest U.S. pharmacies by prescription drug revenue. National Community Pharmacists Association CEO B. Douglas Hoey called the vote "extremely disappointing." "Two members of the FTC just let the worst actors in the market off the hook," Hoey said in an email. In a statement after the vote, the Pharmaceutical Care Management Association, which represents PBMs, didn't address the FTC action and instead pointed the finger at drugmakers for high prescription prices. "PBMs are holding drug companies accountable by relentlessly negotiating the lowest possible cost on behalf of patients and are driving and delivering local competition that patients are demanding," said spokesperson Greg Lopes.
| | | CALIFF GETS TO WORK — Califf officially took office Thursday, beginning his second stint as commissioner with a memo to FDA employees and a series of tweets outlining his priorities. Workforce morale: "I pledge that I will do everything within my power to listen to you and work with you to create the best possible work environment and team spirit," he wrote, a tacit acknowledgment of rank-and-file burnout. Pandemic response: This will continue to be FDA's "primary focus," Califf said, praising agency staff for doing work that gave the world "a solid foundation for life saving medical products." Opioid epidemic: Califf name-checked his recent work "in the field" on the opioid crisis for a Dayton, Ohio, nonprofit — Democratic "no" votes, take note — and said he wants to work with partners at HHS and in the private sector on the government's continued response. "We must accept that all the hard work so far has not been enough," he wrote. Misinformation: Califf also nodded to the effect misinformation has had on the public's response to the Covid pandemic and the importance of FDA working to counteract it. "These kinds of distortions and half-truths that find their way into the public domain do enormous harm, both by leading people to behavior that is detrimental to their health and by causing them to eschew interventions that would improve their health," he wrote. FDA SCHEDULES SURPRISE ADVISORY COMMITTEE MEETING FOR ALS DRUG — FDA's external advisory committee on neurological drugs will meet March 30 to discuss an ALS drug candidate from Amylyx Pharmaceuticals, Katherine reports. The meeting, announced Wednesday, is somewhat unexpected: Less than a year ago, Amylyx announced that, per FDA's guidance, it would be conducting another clinical trial to verify its Phase II results. For those watching the neurodegenerative space, the agency's decision to consider approving a drug without crystal-clear evidence of its benefits feels reminiscent of its decisions with Aduhelm, the contentious Alzheimer's treatment from Biogen. What we're watching: Will FDA ask its advisory committee to explicitly weigh in on whether the accelerated approval pathway is an appropriate mechanism given the evidentiary profile for Amylyx's ALS drug? Since approving Aduhelm via the accelerated pathway in June, FDA has been the subject of heated debates — and an HHS probe — around the accelerated approval pathway, the relationships between drugmakers and FDA and the agency's relationship with the Centers for Medicare and Medicaid Services. Mark McClellan, the director of the Duke-Margolis Center for Health Policy at Duke University and former FDA commissioner, suggested a "new kind of expediting approval pathway or standards for trials" may be prudent to establish, given the Aduhelm fallout. "It's almost certainly going to be the case that there will be important post-market questions," McClellan said of the Amylyx candidate.
| | | BIDEN ADMIN PREPPING NEW TESTING INVESTMENTS — The federal health department on Wednesday formally requested ideas from the diagnostic testing industry on how the U.S. can sustain the domestic manufacturing capacity of Covid-19 tests over the next year. "We know that as Omicron cases decline, demand for tests will wane as well," Tom Inglesby, senior adviser to the White House Covid response, told reporters. HHS on Tuesday made the case to congressional appropriations that $30 billion in additional funds is necessary for future pandemic response efforts, including sustaining testing capacity. "As always, the administration is working closely with congressional leaders on the Covid response, and we know that there is bipartisan support for ensuring we sustain and expand the domestic manufacturing base and are able to deal with all testing needs in the response to new variants or any future surge," a White House official said.
| | | CONGRESS IS NOT KEEN ON SPENDING MORE ON COVID PREP — President Joe Biden's cabinet members and public health experts say they are running out of money to battle Covid-19 and need tens of billions more dollars to continue vaccination, testing and medicine distribution efforts at home and abroad — but lawmakers aren't eager to spend more, POLITICO's Alice Miranda Ollstein reports. The push for a Covid supplemental bill, which would ride alongside the package to fund the government through September that Congress is trying to pass by mid-March, is encountering bipartisan resistance. GOP lawmakers argue more spending will exacerbate inflation and that the worst of the pandemic is in the past. And even Democrats who support the additional public health funds worry the effort could derail the fragile negotiations on the core bill to fund the government by injecting partisan disagreements about how to address the pandemic into discussions over funding the military and federal agencies. "I'm not eager to add anything," Senate Appropriations Chair Patrick Leahy (D-Vt.) told reporters this week. "It has taken several months of negotiations to get where we are, and I'm very reluctant to reopen it for anything else." CONGRESS GETS ITS MDUFA BRIEFING — FDA and the medical device industry jointly briefed House Energy and Commerce Committee and Senate HELP Committee staff on the state of ongoing MDUFA negotiations between the two parties on Feb. 9, according to a Democrat HELP Committee aide and a person familiar with the talks. WARREN CALLS ON BECERRA TO 'MARCH IN' ON CANCER DRUG — Sen. Elizabeth Warren urged HHS Secretary Xavier Becerra in a letter Friday to hear and grant a "march-in rights" petition to cut the price of Xtandi, a prostate cancer drug. The Massachusetts Democrat, alongside Sen. Angus King (I-Maine) and Rep. Lloyd Doggett (D-Texas), argues executive action is warranted because federal grants underwrote the patented technology's research.
| | | Judy Stecker has joined Hill+Knowlton Strategies as senior vice president and U.S. health care media and public affairs lead. She was previously a senior official at the Trump-era HHS , serving first as assistant secretary for public affairs and then as deputy chief of staff for operations and strategy. She also led external outreach for Operation Warp Speed and the health department's Covid response work.
| | | This week, BioNTech unveiled modular mRNA vaccine production hubs it said will bring increased manufacturing capabilities to Africa — and the potential to decentralize the supply of shots in the future, POLITICO's Ben Leonard reports. The Biden administration is turbocharging its effort to boost inoculations in low- and middle-income countries to prevent new, more-transmissible variants from emerging, but the effort is facing a major obstacle: It is running out of money to support the global vaccination push, and negotiations with Congress on securing new funding have stalled, POLITICO's Erin Banco writes.
| | | | A message from the Coalition for Affordable Prescription Drugs (CAPD):   | | | | | | Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for FDA. FDA advisory panel votes against intravenous tramadol — An FDA advisory committee this week voted against recommending approval for an intravenous version of the opioid drug tramadol. The committee — an external group of experts convened by the FDA to offer non-binding but influential advice — expressed concern about the potential for opioid "stacking." Specifically, advisors said the delayed onset of intravenous tramadol, which can take a few hours to take effect, raises the likelihood that patients may subsequently receive other opioids to deal with their immediate pain (the "stacking"), thereby increasing the likelihood of an adverse event like an overdose. The committee voted 14-8 that the sponsor of the drug, Avenue Therapeutics, had not submitted "adequate information to support the position that the benefits of their product outweigh the risks of the management of acute pain severe enough to require an opioid analgesic" in the inpatient setting. FDA rejection of petition a potential warning to short-sellers — The FDA last week rejected a petition calling for its investigation into alleged data "anomalies" in another company's drug submission — a rejection which seems to be aimed as much at Wall Street as it is at the petitioner. FDA was responding to a Citizen Petition which alleged that Cassava Sciences, a developer of the Alzheimer's disease drug Simufilam, had published data "suggestive of systemic data manipulation and misrepresentation," and sought a halt to the company's clinical studies while the FDA investigated and referred the findings to law enforcement. However, FDA said investigations can't be requested through the petition process, and any response would violate federal law (the Trade Secrets Act) meant to protect commercially confidential information. Regardless, the agency did indicate that it may still take action through other means and took the concerns of the petitioner "seriously." According to AgencyIQ's analysis, FDA's action seems geared toward limiting petitions from market-motivated short-sellers who might otherwise use the petition process to bury FDA reviewers in unnecessary petitions. At the same time, the FDA did not indicate an alternative preferred venue for receiving concerns about data integrity issues.
| | | FDA is holding a virtual workshop alongside the Veterans Health Administration on March 16-17 to discuss point-of-care 3D printing of medical devices in hospitals. FDA on Thursday published 43 product-specific guidances for generic drug development.
| | A message from the Coalition for Affordable Prescription Drugs (CAPD): Americans aren't fooled by Big Pharma. According to new polling, 80% of Americans want Congress to rein in big drug companies' skyrocketing prices. American voters clearly know that big drug companies bear responsibility for high drug prices and are looking to Congress and the Administration to take immediate action to protect patients. Learn more. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |
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