Schumer wants Congress to take another shot at drug pricing legislation

Presented by the Pharmaceutical Care Management Association (PCMA): Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.

Mar 08, 2022 View in browser   By David Lim and Katherine Ellen Foley Presented by the Pharmaceutical Care Management Association (PCMA) With Alice Miranda Ollstein On Tap — Schumer wants another run at a drug pricing package, but Democrats are tempering expectations. — Pallone wants changes to FDA's accelerated approval program. — Cepheid won a large contract to supply tests to the government that can detect Covid-19 and other respiratory diseases. It's Tuesday. Welcome back to Prescription Pulse. Cherry blossom watch: Peak bloom isn't expected until March 22, but already some of these beauties are peeping out around town. Send tips, feedback and cherry blossom pics 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 (PCMA): Over the past half decade, brand pharmaceutical manufacturers have undertaken a massive campaign to deflect blame for their pricing decisions. Ironically, the industry that controls the list price of prescription drugs has attempted to point the finger at those focused on reducing the cost of prescription drugs for patients and payers. We urge Congressional negotiators to continue to resist the latest attempts to shift the blame that puts profits over patients.   In Congress DEMS TAMP DOWN EXPECTATIONS FOR A BBB REVIVAL — Don't call it a comeback. Senate Majority Leader Chuck Schumer told senators in a letter Monday that the chamber would take another run at a package that lowers the cost of prescription drugs and tackles other unrelated items. The Senate Finance Committee is putting together a hearing for next week specifically focused on how to make drugs cheaper, Alice reports. But aides and lawmakers say it's too soon to officially declare that Build Back Better — er, sorry, we mean " Building a Better America" — is back from the dead for several reasons. — The hearing is just to test the waters. A senior Democratic aide told RxP that the Finance Committee's upcoming hearing won't be on the reforms package that passed the House last year, which included Medicare drug price negotiation, inflation caps and insulin-specific protections. Neither will it unveil any new proposals. Instead, the aide said, it's simply a hearing about "the need to take action on high drug prices. It's about giving members space to talk about what's important to them." — They have to fund the government first. Congress is still fighting over the details of the omnibus 2022 budget and supplemental spending bill that funnels billions to Covid aid and the war in Ukraine. Current funding runs out Friday, but congressional leaders are nearing a final deal on a $1.5 trillion government funding package, aiming to release bill text today and clear the measure before the next shutdown deadline hits. — Negotiations haven't yet begun in earnest. Sen. Joe Manchin (D-W.Va.), who yanked support for the package in December, recently outlined the elements he's open to including in the don't-call-it-BBB package, listing drug pricing, tax reforms and climate as a starting point. But he said on Sunday there are "no formal talks going on." The senior Democratic aide echoed this assessment, saying "conversations are happening on what's possible." — All the same divisions that derailed things in December are still there. While Democrats broadly agree on tackling drug prices, taxing the rich in some fashion and combating climate change, they are nowhere near agreement on the details. "We have to deal with the reality of a 50-vote margin when we have two members who don't agree with the other 48," Sen. Chris Murphy (D-Conn.) said in reference to Sens. Manchin and Kyrsten Sinema (D-Ariz.). E&C CHAIR INTRODUCES BILL TO CHANGE ACCELERATED APPROVAL PROGRAM — House Energy and Commerce Committee Chair Frank Pallone (D-N.J.) introduced a bill Monday that would modify FDA's accelerated approval program. The bill, called the Accelerated Approval Integrity Act of 2022 , would hasten FDA's data collection of drugs approved through the pathway to guarantee that treatments actually benefit patients. The context: The accelerated approval program allows FDA to approve therapies for serious conditions without ample existing treatments by using metrics other than patient survival or quality of life. To verify that those metrics, called surrogate endpoints, translate into improved patient outcomes, FDA requires all drugs approved via accelerated approval to undergo another randomized clinical trial while on the market. Last June, FDA used this program to approve Aduhelm, a contentious Alzheimer's drug from Biogen, and this year Medicare proposed to cover it — and all future drugs that work similarly — only for patients enrolled in a CMS-cleared randomized trial. The controversy has made its way to Capitol Hill, where lawmakers brought up the program again and again at a hearing on user fee agreement reauthorization by the House Energy and Commerce Health Subcommittee in February. The details: Pallone's bill would require FDA to add more regulatory structures to the accelerated approval program — particularly around post-marketing trials. The legislation would allow FDA to codify requirements for post-market trials and to detail procedures to revoke a drug's approval if post-marketing trials don't pan out or haven't been completed after five years. "Under the current system, some products have been allowed to stay on the market for far too long without clinical trials that demonstrate a real clinical benefit for patients," Pallone said in a statement.   HAPPENING TODAY, INTERNATIONAL WOMEN'S DAY, AN IMPORTANT CONVERSATION ON THE WOMEN IN AFGHANISTAN: Join Women Rule editor Elizabeth Ralph for a panel discussion on the future for Afghan women. Guests include Hawa Haidari, a member of the Female Tactical Platoon; Cindy McCain, U.S. ambassador to the United Nations Agencies for Food and Agriculture; Roya Rahmani, Afghanistan's first female ambassador to the U.S.; and Sen. Jeanne Shaheen (D-N.H.). Learn how female Afghan veterans are planning their futures, what the women still in Afghanistan face, and what the U.S. can do to help. REGISTER HERE.     Eye on FDA CALIFF OPENS FDA MEETING FOR RARE DISEASE DAY — FDA Commissioner Robert Califf made one of his first public appearances of his second tenure at his agency's Rare Disease Day virtual public meeting Friday where he discussed therapeutic development for rare diseases. "It's very hard for the public to grasp how much work there is involved," Califf said during his opening remarks. "Scientists think of great ideas; patients and families hope for the best. But in the end, it's a back and forth between the FDA reviewers and those developing therapies over the course of sometimes many years because sometimes things don't work, and you have to make adjustments." FDA ANNOUNCES RESEARCH FUNDING VIA BIOSIMILAR USER FEE AMENDMENTS III — FDA announced Monday research grant opportunities to investigate biosimilar and interchangeable biological product development and regulatory science. The funding — mentioned in FDA's commitment letter for the third iteration of the Biosimilar User Fee Amendments — has not yet been formally passed into law by Congress. PARENTS DEMAND ANSWERS FROM FDA ABOUT TIMING OF FORMULA RECALL — Two weeks after a nationwide recall of infant formula tied to five hospitalizations and two deaths, FDA is refusing to answer questions about why it took months to act, POLITICO's Helena Bottemiller Evich reports. The agency, CDC and formula maker Abbott Nutrition knew about the first infant seriously sickened by a rare bacterial infection in September 2021, but FDA didn't investigate the plant where the formula was made until more than four months later. It took another three weeks to order a recall. FDA has not answered POLITICO's questions regarding the lag between the first cases and agency action. Around the Agencies FTC EXTENDS BRIEFING SCHEDULE ON ALTRIA-JUUL DEAL — Federal Trade Commissioners appealed an administrative law judge's decision to allow Altria to acquire more than a third of Juul's shares — which means the agency won't announce a final decision until the end of May. An administrative law judge ruled in favor of the deal last month. The deal has been in the works for nearly four years; Altria initially purchased a 35 percent stake in the e-cigarette company for $12.8 billion in 2018. FTC intervened in 2020, arguing the agreement would violate antitrust laws by stifling competition in the vaping industry.   A message from the Pharmaceutical Care Management Association (PCMA):   In the courts DOJ: MALLINCKRODT TO PAY $260M TO SETTLE LAWSUITS — The Department of Justice said Monday that Mallinckrodt agreed to pay $260 million to resolve allegations it underpaid Medicaid rebates for Acthar, an injectable hormone used to treat a number of conditions including multiple sclerosis and arthritis, and used a foundation to co-pay subsidies for the drug. Coronavirus SECOND ROUND OF FREE AT-HOME TESTS KICKS OFF — Households can now order a second set of four at-home Covid-19 tests from covidtests.gov, President Joe Biden announced Monday. "Even if you don't think you need them now, grab some to have on hand just in case and be prepared," White House National Covid Response Supply Coordinator Tim Manning tweeted. CEPHEID AWARDED $565M CONTRACT FOR POC COVID TESTS — The Department of Defense announced Friday it awarded an 18-month $565.8 million contract to California-based Cepheid for multiplex point-of-care nucleic acid amplification tests that detect Covid-19, flu and respiratory syncytial virus. HHS' Office of the Assistant Secretary for Preparedness and Response helped with the procurement, which is being paid through American Rescue Plan Act funds.   DON'T MISS POLITICO'S INAUGURAL HEALTH CARE SUMMIT ON 3/31: Join POLITICO for a discussion with health care providers, policymakers, federal regulators, patient representatives, and industry leaders to better understand the latest policy and industry solutions in place as we enter year three of the pandemic. Panelists will discuss the latest proposals to overcome long-standing health care challenges in the U.S., such as expanding access to care, affordability, and prescription drug prices. REGISTER HERE.     Pharma Moves Wendy Parker Sussman has joined Johnson & Johnson as the head of pharmaceuticals for U.S. federal affairs. She left her position at EMD Serono for the role. Pharma Worldwide GLOBAL HEALTH FUNDERS ARE MOVING ON FROM THE PANDEMIC — Prominent global health leaders have started thinking about the pandemic as an endemic virus to be managed, a view that's at odds with those advocating for the populations most vulnerable to new Covid-19 variants and those pushing for future pandemic preparation, POLITICO's Erin Banco reports. Public health advocacy groups are pushing the Biden administration to take a more active role in building infrastructure to produce mRNA vaccines, POLITICO's Daniel Payne reports. Moderna pledged on Monday to "never enforce" its patents for Covid-19 vaccines against manufacturers that are based in or producing in 92 low- and middle-income countries, a shift for the biotechnology firm that has come under pressure to share its mRNA technology to help address global vaccine inequity, POLITICO's Krista Mahr reports. Quick Hits For Undark Magazine, Saima Sidik chronicles why the tie between mental health side effects and birth control has eluded scientists. Document Drawer CMS sent a proposed rule to establish a radiation oncology model to the White House Office of Management and Budget on Friday for review.   A message from the Pharmaceutical Care Management Association (PCMA): Over the past half decade, brand pharmaceutical manufacturers have undertaken a massive campaign to deflect blame for their pricing decisions. Ironically, the industry that controls the list price of prescription drugs has attempted to point the finger at those focused on reducing the cost of prescription drugs for patients and payers. We urge Congressional negotiators to continue to resist the latest attempts to shift the blame that puts profits over patients.     Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM   Follow us

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