In the weeks leading up to the introduction of the American Health Care Act, aka Trumpcare, and for days following it, the silence emanating from Washington, DC trade associations closely aligned with pharmaceutical issues—PhRMA, BIO, NACDS and AAM (formerly the Generic Pharmaceutical Assn.) was deafening. A few weeks before the AHCA bill was introduced, the National Pharmaceutical Council (a much smaller organization than PhRMA) noted that “considering the ongoing debates about the future of the Affordable Care Act, stakeholders need to work together to successfully offer a solution that promotes innovation, incentivizes high-value care and improves health outcomes.” (More about “outcomes” in a moment.) NACDS, as part of an “access agenda” campaign that happened to be running as the bill was introduced, offered that Congress should “ensure any changes to the Affordable Care Act–and to Medicaid and Medicare–do not further reduce payments to pharmacies and jeopardize patient access.” And that was about it.
The contrast with the original Affordable Care Act (Obamacare) and PhRMA is dramatic—back then, PhRMA, under the leadership of Billy Tauzin, famously made a pact with the Obama administration that it would support the legislation, provided that the perennial topics of Medicare negotiating drug prices and drug re-importation were off the table. Critics of PhRMA (and there are many) suggested that the association was simply seeking to expand its potential pool of medicine consumers; on the other hand, the industry is still in effect paying for closing the Medicare Part D “doughnut hole” through a 50% discount for Medicare drugs for seniors. Tauzin left PhRMA not long after ACA passed into law, with some criticism that he allowed the industry to give too much away.
Part of the silence by the Washington, DC trade associations is, as the saying goes, they have no dog in the fight. The new AHCA is only about health insurance, about which associations for healthcare professionals, hospitals and some insurers have a *lot* to say—mostly negative. (The American Hospital Assn. fears $400 billion in lost payments.) By contrast, the ACA had much, much more about healthcare and medicine, besides insurance issues, and many of these are important parts of healthcare delivery today:
The ACA had nine titles (plus a tenth, for text changes to the other nine); only two of them pertain to insurance and Medicaid expansion. The other seven have and will have dramatic effects on how healthcare delivery is carried out in the US. In the couple of years after ACA rules began to go into effect, there were significant reductions in the annual growth of healthcare costs (how much of this could be tied directly to ACA is an open question; on the other hand, higher cost inflation had been predicted by ACA critics).
It’s probably wise for PhRMA and the other leading associations to lie low while AHCA is thrashed out; President Trump has hinted that cost-cutting of drug prices is in the works regardless, so why alienate him more than necessary in anticipation of that debate? But the contrast with 2010 is dramatic; the pharma industry and pharmacy businesses regularly assert how central they are to healthcare delivery, but for now, they’re sitting on the sidelines. PhRMA’s current promotional campaign, seen as TV ads for “goBoldly.com,” and to which (according to press accounts) “tens of millions of dollars” is being devoted, rings a little hollow.
Understanding the FDA's Exemption for DSCSA Compliance
November 12th 2024In the quest for achieving full traceability, the exemption applies to certain trading partners under the Act, and postpones enforcement of final compliance requirements while acknowledging progress and ongoing challenges.