Congress has kept key drug assistance funding at $900.3 million annually since 2014. New enrollments for state programs jumped 30% from 2022 to 2024, in part because states cut off pandemic-era Medicaid assistance. As of January, at least 18 states have pulled back their Ryan White AIDS Drug Assistance Programs, known as ADAPs, in some way.
Pharmacy benefit managers (PBMs) are opaque intermediaries-and they are unpopular with figures including Mark Cuban, who told Fortune that the way they bargain over drug prices is absurd, something that would never happen at the very same pharmacies buying a package of Pringles potato-chip products.
The IRA requires drugmakers to sell selected patented drugs to the government for its Medicare Parts B & D programs at a stipulated "maximum fair price". If they don't agree to these prices, then they face tax penalties on sales of the drug exceeding their profits from it, or the exclusion of all their drugs from Medicare and Medicaid purchases. This would foreclose access to up to 160 million patients, accounting for around 40% of US prescription drug spending or 20% of global prescription drug spending.
The Food and Drug Administration commissioner's effort to drastically shorten the review of drugs favored by President Donald Trump's administration is causing alarm across the agency, stoking worries that the plan may run afoul of legal, ethical, and scientific standards long used to vet the safety and effectiveness of new medicines. Marty Makary's program is causing new anxiety and confusion among staff already rocked by layoffs, buyouts, and leadership upheavals, according to seven current or recently departed staffers.
The 340B program allows hospitals to buy outpatient drugs at steep discounts, with the purported purpose of helping them fund care for low-income and uninsured patients. The now-axed rebate model would have invited drugmakers to participate voluntarily in a rebate-based discount system. Basically, instead of the provider receiving a discount upfront at purchase, the 340B discount would be applied after purchase via rebate - and subject to tedious data submission requirements.
The idea echoes a policy implemented during his first term, when Trump suggested that requiring hospitals to post their charges online could ease one of the most common gripes about the health care system the lack of upfront prices. To anyone who's gotten a bill three months after treatment only to find mysterious charges, the idea seemed intuitive. "You're able to go online and compare all of the hospitals and the doctors and the prices,"
This week in Other Barks & Bites, IPWatchdog's IP news roundup: the House of Representatives passes drug patent legislation, while antitrust legislation targeting patent-related activities is introduced into the Senate and the Trump administration mandates pricing information for pharmaceutical ads; the Patent Trial and Appeal Board (PTAB) issues a pair of precedential decisions on cases with multiple petitions; the USPTO issues marijuana-related trademark guidelines and a notice on modifying patent term adjustment practices;
The U.S. Food and Drug Administration is reportedly mulling whether more prescription drugs should be sold over the counter (OTC) at pharmacies. In an interview on Wednesday, FDA commissioner Martin Makary told CNBC that everything should be over the counter except drugs that are deemed unsafe or addictive or that require clinical monitoring. Makary said the agency is reviewing how it decides which drugs can be sold with or without a prescription from a health care practitioner.
For years, Congress has signaled that it wants to crack down on Pharmacy Benefit Managers, the middle men that have come under fire for their vertical integration with insurers and their role in spiking drug costs. This week, it finally happened via the Consolidated Appropriations Act of 2026, promptingemployer groups including the Purchaser Business Group on Health (PBGH) and the ERISA Industry Committee to cheer its passage.
