Dems blast bills to reopen IRA

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Mar 01, 2024 View in browser   By Lauren Gardner and David Lim Driving The Day Rep. Frank Pallone opposes new legislation involving drugs for rare diseases, saying the bills would hinder innovation and patient access. | Francis Chung/POLITICO E&C DEMS PAN ‘RARE’ IRA CHANGES — Two senior House Energy and Commerce Democrats said Thursday they oppose three bipartisan bills that would broaden rare-disease drug safe harbors from Medicare’s new price negotiation program. The resistance from the panel’s top Democrat, Rep. Frank Pallone of New Jersey, and the health subcommittee’s ranking member, Rep. Anna Eshoo (D-Calif.), likely dooms what would have been a long-shot effort in an election year — with Democrats controlling the Senate and the White House — to tweak portions of the Inflation Reduction Act , President Joe Biden’s signature legislative achievement. It also came on Rare Disease Day, which falls on the last day of February. “Medicare drug price negotiation is only focused on the top-selling, high-cost Medicare drugs without any market competition,” Eshoo said at a hearing on 18 bills, most of which are focused on rare disease issues. “The bills before us today attempt to create unneeded loopholes to chip away at Medicare’s power to negotiate and will raise costs for beneficiaries and taxpayers.” The bills in question: One measure would expand the program exemption for so-called orphan drugs — FDA-designated products for rare conditions that qualify for certain pre- and post-approval benefits to encourage development — to include drugs treating multiple rare diseases. Another bill would keep certain gene therapies out of the program for 11 years after their debut. And a third would phase in plasma-based medicines to the manufacturer discount program. Is past prologue? Big legislative packages are often amended in later years once lawmakers realize unintended consequences or outright errors passed into a statute. Rep. Wiley Nickel (D-N.C.), who co-sponsored all three IRA-related bills, suggested in December that, since the Affordable Care Act was “refined” over the years since its 2010 passage, the same was likely for the IRA. But Pallone made it clear he thinks the law’s existing orphan drug exclusion, which shields products treating a single rare disease from negotiations, is sufficient to protect innovation while saving beneficiaries money. “I don’t know what the point is in having a drug if you can’t buy it and you can’t use it,” he said. On other bills: Pallone signaled hesitation about advancing several other bipartisan bills considered Thursday that would require FDA resources to implement without hearing first from the agency. That includes a bill co-sponsored by Eschoo to reauthorize the FDA’s priority review voucher program for rare pediatric diseases. IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. Is anyone else already getting started on their allergy medicine this year? Send news and tips to Lauren Gardner (lgardner@politico.com or @Gardner_LM) or David Lim (dlim@politico.com or @davidalim). Eye on the FDA FDA Commissioner Robert Califf is under fire from pharmacy compounders over remarks he made about compounded weight-loss drugs. | Manuel Balce Ceneta/AP HITTING BACK AGAINST CALIFF — The trade association for pharmacy compounders urged FDA Commissioner Robert Califf to walk back comments he made this week that the group says conflates legitimately compounded weight-loss drugs with counterfeit versions. What Califf said: “People are attracted to compounded versions of this without the requisite controls to make sure that what you’re buying is actually the active drug and not something that’s contaminated or not even the active drug at all,” Califf said, noting ongoing shortages of brand-name options by drugmakers Eli Lilly and Novo Nordisk. “We could use more authority in the area of compounding and control of illicit markets that happen on the internet,” he later added. “That’s a very difficult area.” Compounders respond: Alliance for Pharmacy Compounding CEO Scott Brunner said the direct-to-consumer sale of any substance advertised as an FDA-approved drug without a prescription is illegal. Califf’s comments, Brunner added, could spur patients to question the safety and legitimacy of compounded drugs prescribed to them. “APC strongly supports FDA’s efforts to end the sale of illicit substances, which put consumers at risk,” he said in a statement. “At the same time, we urge the agency to take care in enunciating the difference between actual counterfeit products and legitimate compounded drugs.”   CONGRESS OVERDRIVE: Since day one, POLITICO has been laser-focused on Capitol Hill, serving up the juiciest Congress coverage. Now, we’re upping our game to ensure you’re up to speed and in the know on every tasty morsel and newsy nugget from inside the Capitol Dome, around the clock. Wake up, read Playbook AM, get up to speed at midday with our Playbook PM halftime report, and fuel your nightly conversations with Inside Congress in the evening. Plus, never miss a beat with buzzy, real-time updates throughout the day via our Inside Congress Live feature. Learn more and subscribe here.     Coronavirus SPRING (BOOST) AHEAD — The CDC endorsed its outside expert panel’s recommendation Wednesday that adults 65 and older should receive an additional Covid-19 shot with the current formulation. The agency’s Covid working group had proposed a less stringent recommendation that those individuals “may” get another dose, but some advisers worried that would foment confusion among patients and providers about the vaccine’s benefits. Still, CDC and FDA officials noted that the greater public health benefit would come from convincing the 60 percent of older adults who haven’t gotten a first dose of the updated vaccine to roll up their sleeves. Drug Pricing DEAL OR NO DEAL? Drugmakers selected for the first Medicare drug price negotiations have until March 2 to decide whether to accept CMS’ initial price offer or put forward a counteroffer. If CMS does not accept each company’s price counteroffer, the two sides will meet up to three times to negotiate a maximum fair price for the selected drugs that will kick into effect in 2026 — but the details of the talks will not be made public unless disclosed by drugmakers. “CMS will not publicly discuss ongoing negotiations with a participating drug company, except if a participating drug company discloses information about the negotiations that is made public prior to CMS releasing an explanation of the negotiated price,” CMS said in an emailed statement. One drugmaker, Novartis, said it does not plan to say whether it will give a counteroffer to CMS. “We don’t have plans to share this,” said Novartis spokesperson Michael Meo. What’s next: The negotiation window for the first set of drugs ends on Aug. 1. CMS is required to release an explanation of the final prices no later than March 1, 2025. In Congress ANOTHER CONTINUING RESOLUTION — The House agreed on another stopgap spending bill Thursday afternoon, which kicks funding deadlines for the government until March 8 for six bills, including one that funds the FDA, and March 22 for the other six. The Senate cleared the bill Thursday night for President Joe Biden’s signature. Pharma Worldwide ANOTHER PANDEMIC DEAL ROADBLOCK — Developing countries rejected a pathogen data-sharing proposal at the World Health Organization this week, POLITICO’s Rory O’Neill reports, dashing hopes for a breakthrough in negotiations over a new pandemic deal. A bloc of Global South countries considered the proposed agreement on benefit sharing too vague. It would have directed manufacturers — at the WHO’s request — to supply 10 percent of vaccines, drugs and diagnostic tools for free and another 10 percent at nonprofit prices during a crisis, with the allocations tied to legally binding contracts. CANADA UNVEILS DRUG PLAN — The Canadian government released a proposal Thursday to establish a national, single-payer system for prescription drug coverage. The legislation is billed as the program’s first phase, which would initially cover contraception and diabetes drugs. Document Drawer CMS published final guidance on Thursday for the Inflation Reduction Act’s Medicare Prescription Payment Plan.   YOUR TICKET INSIDE THE GOLDEN STATE POLITICAL ARENA: California Playbook delivers the latest intel, buzzy scoops and exclusive coverage from Sacramento and Los Angeles to Silicon Valley and across the state. Don't miss out on the daily must-read for political aficionados and professionals with an outsized interest in California politics, policy and power. Subscribe today.       Follow us on Twitter David Lim @davidalim Lauren Gardner @Gardner_LM   Follow us

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