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Presented by Pharmaceutical Care Management Association: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | |  | | By David Lim and Katherine Ellen Foley | Presented by Pharmaceutical Care Management Association | | | | | 
Sen. John Cornyn's Affordable Prescription for Patients Act is on Congress' agenda next week. | Win McNamee/Getty Images | SENATE JUDICIARY TO REVISIT DRUG PRICING BILLS — Lawmakers on the Senate Judiciary Committee are not wasting time revisiting a package of bills that aim to increase competition to brand drugs. The committee is expected to mark up five bipartisan bills next week that aim to boost coordination between the FDA and the U.S. Patent and Trademark Office, direct the Federal Trade Commission to study the role of pharmacy benefit managers in the supply chain, limit pay-for-delay agreements and deter use of citizen petitions that aim to delay competition. “All five of the drug pricing bills on our agenda are bipartisan, and each was reported out of committee last Congress by voice vote,” a Democratic Senate Judiciary Committee aide granted anonymity to speak freely about the legislation told POLITICO. “They relate to an issue Americans care about — the cost of prescription drugs — and we believe they all have a good chance of moving through the full Senate.” Sen. John Cornyn (R-Texas) plugged his bipartisan bill set for consideration on the Senate floor Thursday — the Affordable Prescriptions for Patients Act —which aims to facilitate competition by addressing product hopping and placing limits on the number of patents biologic manufacturers can assert during what is known as the patent dance. “There’s a bipartisan desire to stop the anti-competitive behaviors that I described here today that are costing patients and taxpayers a fortune, and I hope we can make progress this Congress and finally put a stop to some of the gamesmanship,” Cornyn said. IT'S FRIDAY. WELCOME TO PRESCRIPTION PULSE. We’re not sure what to make of this one: According to Punxsutawney Phil, we’ve got six more weeks of winter ahead, but D.C.’s own Potomac Phil ruled we’ll have an early spring. Send tips, feedback and your favorite groundhog meteorologists to David Lim (dlim@politico.com or @davidalim) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). TODAY ON OUR PULSE CHECK PODCAST, Megan Messerly talks with Ruth Reader about the Federal Trade Commission's action against drug discount platform GoodRx for sharing customers' health data with Google, Facebook and other third parties.
| | | | | A message from Pharmaceutical Care Management Association: Pharmacy benefit managers, PBMs, strongly support biosimilars. They increase competition, provide health plans greater choice, and lower patient drug costs. New research confirms that once multiple biosimilars reach the market, prices decline and coverage increases. Learn more about the benefits of a competitive biosimilar market and how PBMs’ policy recommendations would increase patient access to biosimilars and enable PBMs to secure greater prescription drug savings for employers, health plans, and ultimately patients and taxpayers. | | | | | | | 
Emergency authorizations will continue after the public health emergency lifts, the FDA says. | Rick Bowmer/AP Photo | FDA: PHE END WILL NOT IMPACT EMERGENCY AUTHORIZATIONS — The White House’s announcement that it will end the Covid-19 public health emergency — and a separate Covid national emergency — on May 11 will not pull medical products with emergency use authorization off the market, the FDA said. “The FDA intends to issue a Federal Register notice regarding how HHS’ determination to end the Covid-19 public health emergency declared under the Act will impact the Agency’s COVID-19-related guidances and which of those guidances it is temporarily extending or letting expire,” the agency tweeted on Tuesday. “The agency may continue to issue new EUAs going forward when criteria for issuance are met.” Pfizer said Tuesday that, as its federal contracts wind down, it expects its Covid-19 vaccines and antivirals will bring in significantly less revenue for the company, which brought in more than $100 billion in 2022 partly because of its pandemic products, Katherine reports. FDA STRIKES TESTING REQUIREMENT TO PRESCRIBE COVID ANTIVIRALS — Doctors no longer need a positive Covid-19 test to prescribe Paxlovid or Lagevrio for certain patients under a change announced by the FDA on Wednesday. The agency revised the emergency use authorizations for the antivirals to allow doctors to prescribe them to patients that recently had a known Covid-19 exposure, have mild-to-moderate symptoms and are at high risk for severe disease, even if they have a negative test result. The FDA said it continues to recommend doctors use testing to diagnose Covid. CASSIDY BECOMES TOP HELP GOP LAWMAKER — Sen. Bill Cassidy (R-La.) officially became the ranking member of the Senate Health, Education, Labor and Pensions Committee on Thursday following a final parliamentary step. Sen. Bernie Sanders (I-Vt.) — the incoming committee chair — has talked broadly about some items, including wanting to lower health care and prescription drug prices for Americans, but the committee also has some must-do items this session, including reauthorizing a pandemic preparedness measure called the Pandemic and All Hazards Preparedness Act, or PAHPA. In an interview with POLITICO, Cassidy said he wants to examine how expensive gene therapies are paid for, especially in cases where a health benefit for a patient might not be realized for decades. “We’ve got to have a point where no insurance company is disadvantaged as to whether or not they choose to cover a particular gene therapy for somebody,” Cassidy said. “If you find a way in which you truly socialize the cost of that gene therapy — yes, we want to reward innovation, but in which you don’t make it a crapshoot as to what insurance company or small business gets stuck with the bill — then you are going to be able to expand access.” On the House side, Rep. Sanford Bishop (D-Ga.) is slated to be the ranking member on the House Appropriations Agriculture-FDA Subcommittee.
| | | | JOIN POLITICO ON 2/9 TO HEAR FROM AMERICA’S GOVERNORS: In a divided Congress, more legislative and policy enforcement will shift to the states, meaning governors will take a leading role in setting the agenda for the nation. Join POLITICO on Thursday, Feb. 9 at World Wide Technology's D.C. Innovation Center for The Fifty: America's Governors, where we will examine where innovations are taking shape and new regulatory red lines, the future of reproductive health, and how climate change is being addressed across a series of one-on-one interviews. REGISTER HERE. | | | | | | | | FDA REPORT ON 2021 POST-MARKETING TRIALS — On Thursday, the agency published an update of post-marketing trials pharma companies committed to or are required to conduct by the FDA. As of September 2021, there were 83 ongoing trials for therapies that received accelerated approvals; 37 trials for therapies granted accelerated approval were delayed or had been terminated early.
| | | FTC CRACKS DOWN ON COMPANIES THAT SHARE CUSTOMERS’ HEALTH DATA — The Federal Trade Commission on Wednesday took its first action against a company for allegedly violating the 2009 health breach notification rule. The agency reached agreement with GoodRx on a fine and remedies after the prescription discount site and telehealth provider shared customers’ health data with third parties, POLITICO’s Ruth Reader reports. ARPA-H BRINGS ON OMB OFFICIAL— The Advanced Research Projects Agency for Health brought in Barbara Menard from the White House’s Office of Management and Budget to serve as the director of the new agency’s legislative and government affairs office, POLITICO’s Megan R. Wilson reports.
| | | | A message from Pharmaceutical Care Management Association:   | | | | | | President Biden announced six new members of the National Cancer Advisory Board on Thursday. On Tuesday, the Food and Drug Law Institute announced three new board members and two new officers.
| | | FDA Commissioner Robert Califf said no personnel would be fired amid the overhaul of the agency’s food safety programs, POLITICO’s Meredith Lee Hill reports. In the first GOP-led House Oversight and Accountability Committee hearing, oversight officials warned that without changes, the federal government risks being unable to prevent or root out fraud and mismanagement in assistance programs, POLITICO’s Megan R. Wilson reports. Jamie Ducharme writes for Time about how Evusheld’s revoked emergency use authorization leaves immunocompromised adults without tools for fighting Covid.
| | | | JOIN TUESDAY TO HEAR FROM MAYORS AROUND AMERICA: 2022 brought in a new class of mayors leading “majority minority” cities, reshaping who is at the nation’s power tables and what their priorities are. Join POLITICO to hear from local leaders on how they’re responding to being tested by unequal Covid-19 outcomes, upticks in hate crimes, homelessness, lack of affordable housing, inflation and a potential recession. REGISTER HERE. | | | | | | | | On Tuesday, the Government Accountability Office published a report on the early results of the Research to Accelerate Cures and Equity for Children Act. On Thursday, it published a report on HHS’ public health preparedness. On Tuesday, the FDA published draft guidance on conducting external clinical trials for new therapies. The FDA’s Vaccine and Related Biological Products Advisory Committee will meet on Feb. 28 and March 1 to discuss respiratory syncytial virus vaccines from Pfizer and GSK for older adults. The FDA and the Reagan-Udall Foundation will hold a two-day virtual public meeting on March 8 and 9 to discuss product development and public health interventions for overdoses. On Wednesday, CMS released its Calendar Year (CY) 2024 Advance Notice of Methodological Changes for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies, which includes Inflation Reduction Act provisions for 2024, such as the elimination of cost-sharing for Part D drugs for people in the catastrophic phase of coverage.
| | A message from Pharmaceutical Care Management Association: PBMs are strong proponents of a functioning biosimilar market that will increase competition for biologic drugs and provide added choice for health plans and patients. New research confirms that biosimilar competition drives prices lower, leading to increased coverage. Over time, PBMs can more effectively leverage competition to further reduce drug costs for health plans and patients.
The promise of biosimilars in the United States can only be realized if barriers delaying the emergence of competitive biosimilars are eliminated. Too often drug manufacturers take advantage of barriers in the current system. Policies allowing for patent abuse to block access to biosimilars cost American patients $7.6 billion in lost savings since 2015. To unlock the savings potential of biosimilars PBMs support policies that will allow for greater biosimilar adoption.
Learn more about the benefits of a robust biosimilar market and how PBMs’ policy recommendations would increase patient access to biosimilars. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |  |
