| | | | |  | | By Lauren Gardner and David Lim | | | With Megan R. Wilson
| | |  Discussions are underway about restructuring the FDA's Office of Regulatory Affairs. | Sarah Silbiger/Getty Images | FDA’S COMING MAKEOVER — One of the FDA’s biggest tasks for 2024 is taking action on last year’s internal reckoning over how the agency’s structure contributed to its widely criticized response to the infant formula crisis. The proposed reorganization extends far beyond the FDA’s food division. Six FDA officials representing the agency’s past and near future — including outgoing Principal Deputy Commissioner Janet Woodcock and her successor, Chief Scientist Namandjé Bumpus — will discuss the agency’s plan Friday during a webinar hosted by the Alliance for a Stronger FDA, which advocates for increased federal spending for the agency. The goal of the event, per alliance Executive Director Steven Grossman, is for those regulated by the FDA to hear directly from senior officials about how the reorganization will affect them — especially medical product companies, since the restructuring has often been discussed in the context of the embattled food program. The restructuring of the FDA’s Office of Regulatory Affairs “is going to hit every center,” Grossman said, as compliance functions shift to the agency’s drug, biologics and device centers. The FDA has proposed remaking ORA into an Office of Inspections and Investigations. Is past prologue: The FDA is no stranger to reorganizations, with the most recent one taking place in 2019 under then-Commissioner Scott Gottlieb. One former senior FDA official, granted anonymity to discuss the agency’s internal operations, said the most recent iteration appears to build on past work, shifting away from the geographic focus of inspections and to subject matter experts taking the lead. Another former FDA official, also granted anonymity, said the agency had to proceed carefully with the latest changes to ORA since it’s essentially being divided up. Past restructurings were unpopular with employees, who are also represented by a union, the official noted. We’ll be watching to see how FDA officials — particularly Bumpus and Michael Rogers, associate commissioner for regulatory affairs — talk about the new inspections universe and how it will work in practice for medical products. The event can be viewed online. Have any thoughts beforehand or afterward? Drop us a line! We can keep you anonymous. IT’S WEDNESDAY. WELCOME BACK TO PRESCRIPTION PULSE. We’re excited there’s finally a winter wonderland to go along with these chilly temperatures. Send news and tips to Lauren Gardner (lgardner@politico.com or @Gardner_LM) or David Lim (dlim@politico.com or @davidalim).
| | | | | | | A message from the Coalition for Affordable Prescription Drugs: A new report from Matrix Global Advisors (MGA) found that 9 of the 10 prescription drugs with the highest price increases since 2018 DO NOT have rebates. This new data adds to a growing body of work refuting drug companies’ claims that rebates drive up drug prices. The report concludes that to combat high and rising prescription drug prices, Congress should focus on policies that promote drug competition. Read the full report. | | | | | | | 
Fujifilm Holdings America has hired lobbyists to make its presence known as a player in biopharmaceuticals on Capitol Hill. | Koji Sasahara/AP | FROM FILM TO PHARMA — Fujifilm Holdings America wants lawmakers to know that it does more than make cameras, Megan reports. The company is establishing a Washington presence, hiring lobbyists to highlight its biopharmaceutical work as Congress considers ways to help avert drug shortages and increase domestic manufacturing of medicines. Company subsidiary Fujifilm Diosynth Biotechnologies is a partner to some major drugmakers — known as a contract development and manufacturing organization, or CDMO — for biologics, vaccines, advanced therapies and oncolytic viruses, a therapy used to treat cancer. Crystal Fry-Vanuch, who joined the company last year and recently registered to lobby, will oversee its government affairs and policy operation. Fujifilm Holdings America has contracted with Akin Gump Strauss Hauer & Feld, the second-largest lobbying firm in D.C. by revenue, and powerhouse lobby shop CGCN Group. Introductions: The plan is to introduce the company to lawmakers and public health officials and its role in the domestic production of pharmaceuticals as the U.S. continues to grapple with supply-chain issues in the wake of the pandemic, said Joe Metzger, vice president of corporate communications at Fujifilm Holdings America. Supply-chain issues have led to shortages in products such as cancer drugs and asthma medication. Drugmakers largely rely on India and China for many pharmaceutical ingredients, which has prompted a push from lawmakers to move manufacturing back to America. VERTEX GETS SECOND APPROVAL — The FDA approved Vertex Pharmaceuticals’ Casgevy for transfusion-dependent beta thalassemia — a genetic disease that can cause fatigue and shortness of breath — for those 12 years and older, the company said Tuesday. The approval comes weeks after the gene-editing cell therapy was approved for sickle cell disease.
| | | | JOIN 1/31 FOR A TALK ON THE RACE TO SOLVE ALZHEIMER’S: Breakthrough drugs and treatments are giving new hope for slowing neurodegenerative diseases like Alzheimer’s disease and ALS. But if that progress slows, the societal and economic cost to the U.S. could be high. Join POLITICO, alongside lawmakers, official and experts, on Jan. 31 to discuss a path forward for better collaboration among health systems, industry and government. REGISTER HERE. | | | | | | | | CANADA WORKS THE PHONES ON IMPORTS — The Canadian government is working hard to let its American counterparts know that it has no interest in exporting drugs to its neighbor. Health Minister Mark Holland has spoken to HHS Secretary Xavier Becerra and U.S. Ambassador David Cohen in recent days “to express Canada's disappointment with the FDA decision and to advise that Canada will take all necessary measures to protect the Canadian drug supply,” according to a Health Canada readout released Tuesday. “The Minister received assurances that the U.S. Government has no intention of creating challenges for Canada to access drugs or to trigger drug shortages,” the department said.
| | KRATOM STUDY — The FDA said Tuesday it wants better research on the abuse potential of botanical kratom. The agency opened a grant application to study kratom, which an estimated 1.9 million Americans 12 and older used in 2022. “Kratom alkaloids have demonstrated both affinity and activity at mu opioid receptors, receptor sites known to be associated with abuse,” the grant description states. “Although Kratom use is prevalent, to date, clinical evaluations of abuse potential have not been performed.” The FDA has been critical of kratom, and both the Trump and Obama administrations attempted to ban the substance before pulling back after consumer and manufacturer blowback.
| | | | A message from the Coalition for Affordable Prescription Drugs:   | | | | | NEW DEADLINE FOR FDA FUNDING — President Joe Biden has summoned congressional leaders to meet at the White House today to discuss negotiations over national security spending, just days before lawmakers must pass another stopgap measure to keep the lights on at the FDA and other agencies. Leaders reached a deal over the weekend on a continuing resolution to extend funding for the FDA and the VA through March 1 and for HHS through March 8 at fiscal 2023 levels. Whether Congress can reach a long-term appropriations deal will likely hinge on the ability of House Speaker Mike Johnson to assuage his right flank after reaching a $1.7 trillion topline agreement with Senate Majority Leader Chuck Schumer. Appropriations leaders in both chambers continue to negotiate spending allocations for the 12 annual bills. The White House has requested about $4 billion in discretionary spending for the FDA this fiscal year — a more than 10 percent increase over fiscal 2023 levels.
| | | | Enter the “room where it happens”, where global power players shape policy and politics, with Power Play. POLITICO’s brand-new podcast will host conversations with the leaders and power players shaping the biggest ideas and driving the global conversations, moderated by award-winning journalist Anne McElvoy. Sign up today to be notified of new episodes – click here. | | | | | | | | FDA DENIES SEVERAL SMOK E-CIGS — A batch of 22 Smok e-cigarette products received marketing denial orders Tuesday, according to the FDA. “It is the applicant’s responsibility to provide sufficient scientific evidence to demonstrate that marketing a new tobacco product is appropriate for the protection of the public health. In this case, the applicant failed to provide this evidence,” Brian King, director of the agency’s Center for Tobacco Products, said in a press release. MENTHOL MEETINGS MARCH ON — The White House has scheduled meetings on the FDA’s proposal to ban menthol cigarettes into February, according to the Office of Management and Budget’s online schedule. On deck: OMB has set aside time this week for the American Lung Association, the National Latino Officers Association, a wholesale distribution company and associations representing gas stations in Kentucky, Maine and Tennessee. States apply pressure: A coalition of 21 state attorneys general — including those in California, Maryland and North Carolina — urged the White House on Tuesday to move faster to prohibit the sale of menthol cigarettes and flavored cigars. “Compelling and consistent scientific evidence shows that removing menthol cigarettes from the U.S. market and prohibiting characterizing flavors in cigars are likely to reduce youth smoking initiation, improve smoking cessation outcomes in adult smokers, and advance health equity,” the group of AGs wrote.
| | In an interview with STAT, NIH Director Monica Bertagnolli addressed emerging battles over funding for long Covid research and march-in rights that allow the government to claw back patents on products developed with federal funding.
| | The FDA released its Center for Drug Evaluation and Research Office of Compliance annual report for fiscal 2023.
| | | | A message from the Coalition for Affordable Prescription Drugs: A new report from Matrix Global Advisors (MGA) found that 9 of the 10 prescription drugs with the largest list price increases DO NOT have rebates. Among the drugs with the highest list price increases, drugs with no rebates saw increases as high as 413% – with an average price hike of 93%. Among the top drugs with rebates, price increases were much lower – 44% on average. This data clearly refutes drug companies’ claims that rebates drive up drug prices. To combat high and rising prescription drug prices, Congress should focus on policies that promote drug competition, not limit Americans’ pharmacy benefits. Read the full report. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |
