| | | | |  | | By David Lim, Katherine Ellen Foley and Lauren Gardner | Presented by The Pharmaceutical Care Management Association | | | | — Congress is still negotiating an agreement on a legislative package to reauthorize the FDA's user fee programs. — Major tobacco industry players sit down with top FDA officials. — FDA will convene its expert adviser panel in November to discuss over-the-counter birth control. It's Tuesday. Welcome to Prescription Pulse, where your hosts are always amused by unconventional font choices for official Congressional correspondence. Send tips, feedback and your best typeface takes 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 Pharmaceutical Care Management Association: On behalf of 266 million Americans, Pharmacy Benefit Managers, PBMs, negotiate discounts on prescription drugs and improve patient outcomes. According to the GAO, 99.6% of rebates, or discounts, for certain Medicare-covered drugs pass through to health plan sponsors to lower costs for beneficiaries. Patients shouldn't have to worry about high manufacturer drug prices. With a PBM on her side, Brittany's monthly medication costs went from $350 to $5. Learn more about how PBMs protect patients. | | | | | | | 
Congress is back in session, but so far, lawmakers have yet to reauthorize the FDA's user fee programs. | Jay Wescott/POLITICO | WAKE ME UP WHEN SEPTEMBER ENDS — Both chambers of Congress are back in action today for the first time in a month, but a deal to reauthorize the FDA's user fee programs is still not yet hammered out despite weeks of staff-level talks. The four corners of the House Energy and Commerce Committee and the Senate HELP Committee originally aimed to reach a deal on Monday, but the talks have been extended to Thursday, according to a congressional aide and an industry lobbyist granted anonymity to discuss the ongoing negotiations. Seven industry lobbyists and congressional aides say it is likely that major provisions to overhaul the regulation of dietary supplements, cosmetics and diagnostic tests will fall off the user fee package. Lawmakers are instead considering a plan to include those so-called super riders in an end-of-year omnibus government funding package to buy more time to negotiate, four of the industry lobbyists said. But close watchers caution that the ongoing negotiations are still fluid and acknowledge Senate HELP Committee Chair Patty Murray (D-Wash.) is still pushing ranking member Richard Burr (R-N.C.) and House E&C leadership to include the super riders in the final user fee package now. "Staff conversations are ongoing and productive," a senior Senate HELP Committee GOP aide not authorized to comment on the record told Prescription Pulse. "But we'll decline to comment on the substance of any ongoing negotiations." A skinnier user fee package with several smaller riders under negotiation will likely be attached to the continuing resolution on the table, a move that would avert thousands of potential layoffs at the FDA ahead of the midterm elections. "The 'Burrs' have all this leverage right now with the power of just saying 'no,' they've anchored a position with the clean user fee package," a congressional aide granted anonymity said. "They get to enjoy slowly adding things on by way of negotiation with the 'Murrays.'"
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Tobacco industry executives have been meeting with FDA Commissioner Robert Califf and Brian King, the director of the Center for Tobacco Products. | Stephanie Keith/Getty Images | CALIFF, KING CONTINUE MEETING SPREE WITH TOBACCO PLAYERS — FDA Commissioner Robert Califf and director of the Center for Tobacco Products Brian King met with executives from Philip Morris International and Altria last Tuesday, Katherine scoops. The sit-downs with PMI and Altria, the parent company of Philip Morris USA, follow a similar meeting the two FDA officials had with R.J. Reynolds in late August. A spokesperson from Reynolds declined to comment on the meeting's specific content. It's not uncommon for the FDA to schedule conversations with major industry players. "The agency has … to talk to the industry they regulate," a person familiar with the conversations who was not authorized to speak on the matter told Katherine. "The conversations are high level and basic," the person said, noting that it's a chance for the FDA to lay out its regulatory priorities. "It was very clear that the most important item for King and Califf is youth-access prevention." Trade associations, too: The Vapor Technology Association, a trade group advancing the agenda of e-cigarette manufacturers and consumers, tweeted that it, too, had been invited for a meeting with Califf and King last Wednesday. King met with the National Association of Convenience Stores on Aug. 16 on his own to discuss the group's age-verification technology.
| | | | DON'T MISS DIGITAL FUTURE DAILY - OUR TECHNOLOGY NEWSLETTER, RE-IMAGINED: Technology is always evolving, and our new tech-obsessed newsletter is too! Digital Future Daily unlocks the most important stories determining the future of technology, from Washington to Silicon Valley and innovation power centers around the world. Readers get an in-depth look at how the next wave of tech will reshape civic and political life, including activism, fundraising, lobbying and legislating. Go inside the minds of the biggest tech players, policymakers and regulators to learn how their decisions affect our lives. Don't miss out, subscribe today. | | | | | | | | FDA TO CONVENE ADVISERS ON OTC BIRTH CONTROL SWITCH — The FDA announced Monday that it will hold a joint advisory committee meeting on Nov. 18 to gather input on whether it should approve an application for a birth control pill to make the switch from prescription to over the counter. The Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee will consider the first-of-its-kind request. HRA Pharma applied for the switch on July 11; the FDA is expected to make a decision within 10 months.
| | | BIDEN TOUTS NEW ARPA-H DIRECTOR, CANCER MOONSHOT GOALS — Biden traveled to Boston Monday to hype his cancer moonshot initiative now that he's named the first director of the agency he says will be integral to making his goals reality. The new Advanced Research Projects Agency for Health will be led by Renee Wegrzyn — currently at Ginkgo Bioworks but an alum of the Defense Advanced Research Projects Agency, one of the agencies ARPA-H is modeled after. ARPA-H is envisioned as a way to accelerate breakthrough medical discoveries through to launch and implementation, but Biden also focused on another aspect of the biotechnology pipeline: where those technologies are manufactured. He touted an executive order signed earlier in the day that directs federal agencies to boost their efforts to ensure more biomanufacturing occurs in the U.S. instead of abroad.
| | | | A message from The Pharmaceutical Care Management Association:   | | | | | | ESHOO ASKS CMS TO KEEP AT-HOME COVID TESTS FREE — Rep. Anna Eshoo (D-Calif.), chair of the Subcommittee on Health in the House Energy and Commerce Committee asked the Centers for Medicare and Medicaid Services on Monday to keep Covid-19 tests free for beneficiaries after the public health emergency ends — which could be as soon as the middle of next year. "At-home Covid-19 tests have become a routine and important part of our country's mitigation strategies," she wrote in a letter. "It is critical that we maintain robust access to at-home diagnostic tools that can help stop the spread of this virus at any time, particularly since new variants are known to arise."
| | | 340B Health, an association of more than 1,400 hospitals participating in the drug-pricing program, has added Tom O'Donnell as senior vice president of government relations and Eliza Bangit as senior vice president of legal and policy. O'Donnell joins from the National Association of Chain Drug Stores, and Bangit was previously general counsel to the DC Health Benefit Exchange Authority. Annie Woerpel is joining PhRMA as director of federal advocacy. She was most recently a legislative assistant for Rep. Frank Lucas (R-Okla.) and is a Sen. John Boozman (R-Ark.) staff alum.
| | | The FTC released the redacted initial decision of chief administrative law judge D. Michael Chappell on Monday, who earlier this month dismissed antitrust charges brought by the agency against Illumina and Grail.
| | | | Join POLITICO Live on Tuesday, Sept. 20 to dive into how federal regulators, members of Congress, and the White House are seeking to write the rules on digital currencies, including stablecoins. The panel will also cover the tax implications of crypto, which could be an impediment to broader adoption and the geopolitical factors that the U.S. is considering as it begins to draw regulatory frameworks for crypto. REGISTER HERE. | | | | | | | | Republicans across the country are pushing to regulate ballot measures — the grassroots pushes that have led to marijuana legalization, Medicaid expansion and, in some cases, abortion-access protection, POLITICO's Megan Messerly, Alice Ollstein and Zach Montellaro report. Ketamine shows promise in treating medication-resistant forms of depression, Meryl Kornfield reports for The Washington Post.
| | | | A message from The Pharmaceutical Care Management Association: For 266 million Americans, Pharmacy Benefit Managers, PBMs, work to negotiate discounts on prescription drugs and improve patient outcomes. According to the GAO, 99.6% of rebates, or discounts, for certain Medicare-covered drugs pass through to health plan sponsors to lower costs for beneficiaries.
In the face of rising manufacturer drug prices, PBMs lower drug costs by nearly $1,000 per patient every year. PBMs also enable seamless prescription drug delivery to patients, reduce drug interactions and help patients stay on their medication.
With a PBM on her side, Brittany can afford to live a healthier, happier life. Brittany's monthly medication costs went from $350 to just $5.
"My life changed from just existing to living. I was able to form meaningful relationships. I was able to keep jobs long-term and actually move up in companies because my true self was able to shine," Brittany said.
Learn more about how PBMs protect patients. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |
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