Lab test déjà vu

Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.

Jan 12, 2024 View in browser   By David Lim and Lauren Gardner With Ruth Reader and Megan R. Wilson Programming Note: We’ll be off this Monday for Martin Luther King Jr. Day but will be back in your inboxes on Wednesday. Driving The Day The FDA has proposed regulations that could subject laboratory-developed tests to new oversight. | Getty Images WAIT, WAIT — Congress’ window to legislate how laboratory-developed tests are regulated before the FDA moves forward is closing. The FDA is pushing hard to finalize regulations that would subject a swath of medical tests to new oversight, prompting clinical laboratories to lobby lawmakers to step in. The industry hopes Congress can help it avoid new rules that it argues would kneecap access to needed medical tests. The industry is weighing its legal and legislative options to the FDA’s recent proposal, which would start regulating laboratory-developed tests as medical devices — a move it argues is a burdensome overreach of the agency’s authority. The tests in question are diagnostics that individual labs create and use for specific patient needs, such as detecting drug exposure or screening newborns for serious conditions. Until now, FDA scrutiny has been relatively lax, making the agency’s latest push to increase oversight tangible. “We oppose the proposed rule for a number of significant policy reasons,” said Susan Van Meter, president of industry trade group American Clinical Laboratory Association. “We’re going to be hopeful that Congress, as it sees this push that FDA is continuing to make … agrees with us that legislation is far preferable and in the interest of patients and innovation.” There are signals that lawmakers may take up the issue. House Energy and Commerce Chair Cathy McMorris Rodgers (R-Wash.) — who previously led opposition to the VALID Act — called for the FDA to “rescind its proposal and allow Congress to consider the matter. Abigail Keller Carroll, a lawyer in the FDA’s regulatory counsel office in its medical device center, recently was temporarily assigned to Rodgers’ office. And there are rumblings among lobbyists that the Energy and Commerce Committee might hold a hearing on FDA regulation of lab and diagnostic tests this year. IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. We hope this STAT piece about shoddy accommodations for pumping mothers at the J.P. Morgan conference this week forces some change in the conference world and beyond. Send news and tips to Lauren Gardner (lgardner@politico.com or @Gardner_LM) or David Lim (dlim@politico.com or @davidalim).   POLITICO AT CES® 2024: We are going ALL On at CES 2024 with a special edition of the POLITICO Digital Future Daily newsletter. The CES-focused newsletter will take you inside the most powerful tech event in the world, featuring revolutionary products that cut across verticals, and insights from industry leaders that are shaping the future of innovation. The newsletter runs from Jan. 9-12 and will focus on the public policy-related aspects of the gathering. Sign up today to receive exclusive coverage of the show.     In Congress Former Senator Richard Burr sees opportunities in Congress this year for health policy legislation to be passed. | AP Photo BURR WEIGHS IN — Former Senate HELP Committee ranking member Richard Burr (R-N.C.) chatted with POLITICO’s Megan R. Wilson about Congress’ agenda for the coming months. Burr, who retired from Congress last year, is now at law and lobbying firm DLA Piper and serves as chair of the firm’s health policy strategic consulting practice. Does the VALID Act come back this year? It’s easy to answer, will there be a comeback? There has to be. I'm not sure I can tell you it happens this year because this year requires a Ouija board and a snowball to try to figure out what can happen and what will happen because those are two different things. How could this play out? Whether it's [laboratory-developed tests] or whether it’s [the Pandemic and All-Hazards Preparedness Act], there are going to be opportunities. The January funding bill is too early; maybe the February funding bill might work out better. But all health care [policy] is going to ride on another vehicle. But anything pandemic-related has become so politically polarized — with some conservatives opposing any items with the word “pandemic” in it. How does that get resolved? There’s still some passion by members to get it done. And it’s more of a timing issue. If you look at January and February and say, ‘Could you have Covid, RSV and flu all hit at the same time and have a perfect storm and have hospitals inundated?’ … That all can change based upon people’s fear. Congress seems to always act when the fear factor goes up. There’s talk of potential discussions with Rep. Anna Eshoo (D-Calif.) on drug shortages — something Republicans on the House Energy and Commerce Committee bristled at as the PAHPA reauthorization bill came together. What do you see happening there? Never underestimate a retiring member and their need to get something that’s a signature as their last hurrah. FIRST IN RxP: BIPARTISAN GROUP TARGETS PATENT THICKETS — New legislation targeting so-called patent thickets is being introduced by a bipartisan group of lawmakers in the Senate and the House in an effort to boost competition in the prescription drug market. The bill — led by Sens. Peter Welch (D-Vt.), Mike Braun (R-Ind.) and Amy Klobuchar (D-Minn.), and Rep. Jodey Arrington (R-Texas) — would limit the number of patents that brand drugmakers can use when defending a legal challenge to one at once. That would prohibit pharmaceutical companies from using a group of patents protecting small changes to the underlying medicine as a way to defend a single product from generic competition. Eye on the FDA UPDATE ON WEIGHT-LOSS DRUG SIDE EFFECTS — The FDA said Thursday its preliminary assessment of possible side effects of popular diabetes and obesity drugs hasn’t found a causal link between their use and suicidal thoughts or actions. The agency said it “cannot definitively rule out that a small risk may exist” due to the small number of suicidal ideations or attempts observed in people who take the drugs and is continuing to investigate the issue. A number of such instances have been recorded in the FDA’s adverse event database by users or providers of the class of medicines known as glucagon-like peptide-1, or GLP-1, receptor agonists. The system doesn’t establish causation, however, and the FDA said it would analyze both clinical trial and post-marketing data gathered about the drugs. CALIFF: IT TAKES A VILLAGE ON AI — The FDA will need help if it’s going to be the lead federal agency to set rules for artificial intelligence in health care, Commissioner Robert Califf said at the Consumer Electronic Show in Las Vegas this week. Building a system capable of monitoring the algorithms that undergird AI products as they evolve would require doubling the agency’s size. But Califf doesn’t foresee that level of growth and said he’s working to enlist a “community of entities” to assess and certify algorithms. Even so: Califf said he thinks AI can shed light on deficiencies in the health care system and help fix them. “One of the greatest opportunities in AI is to get the gatekeepers out of the way right now who are suppressing a lot of information that would show the problems,” he said. What’s next? Califf said the certification process should aim to root out bias in algorithms in all its potential forms involving race, sex, geography and wealth. Pharma in the States NJ BLOWS DRUG BOARD DEADLINE — New Jersey’s government has yet to appoint members to its new Drug Affordability Council, missing its first deadline to activate the group, POLITICO’s Daniel Han reports. The board is tasked with developing recommendations on legislation and regulations to help lower prescription drug prices in the state.   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.       Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM   Follow us

To change your alert settings, please log in at https://www.politico.com/_login?base=https%3A%2F%2Fwww.politico.com/settings This email was sent to rouf@idiot.cloudns.cc by: POLITICO, LLC 1000 Wilson Blvd. Arlington, VA, 22209, USA Unsubscribe | Privacy Policy | Terms of Service