Representatives of the American Society of Health-System Pharmacists (ASHP) said Monday that despite current political turmoil they anticipate seeing developments on both the federal and state levels regarding drug pricing, provider status, and compounding regulations in the approaching months.
While drug policy decisions are frequently used as bargaining chips in political debates, ASHP Vice President of Government Relations Tom Kraus, JD, said drug pricing is the most likely area to see bipartisan action, mainly because it’s a largely bipartisan issue.
“It’s an exciting area where there is opportunity for us to engage,” he said Monday, at the ASHP Summer Meeting in Boston.
ASHP’s Director of Federal Legislative Affairs Douglas Huynh, JD; Director of Federal Regulatory Affairs Jillanne Schulte Wall, JD; and Director of State Grassroots Advocacy and Political Action Nicholas Gentile, BA, also spoke at the presentation "ASHP Government Relations Update: Advancing Pharmacy Practice Through Proactive Advocacy."
Huynh said the Senate has essentially ignored a small health care tax bill passed by the House on May 9, which included some drug pricing legislation and added some ACA provisions. Instead, Huynh said he believes the Senate is attempting to create its own package on drug pricing, with a possible floor vote later in June. If that passed, the Senate could conference with the House to create a single piece of legislation, which would then be passed to the President Huynh said.
Other legislation currently on the table includes the Creating and Restoring Equal Access to Equivalent Samples Act of 2019 (CREATES Act), which would require brand drug companies to provide sample products to generic brand companies or face potential litigation.
In another effort to tackle drug prices, the Department of Health and Human Services has created an International Index Pricing Proposal, which Wall described as a “pre-rule rule requesting information.” It would be mandatory model requiring physicians and hospital outpatient departments to contract with private-sector vendors.
“We in general are not big fans of mandatory demonstration projects, particularly those that are rolled out nationwide,” said Wall. “There needs to be some background preliminary work done before you can roll out a huge, very destructive policy across the country, and that just hasn’t been done here.”
If a proposed rule is eventually released, Wall said ASHP would do a more in-depth analysis via webinar or something similar.
“If we don’t hear anything in the next 5 months, my guess is this has been put on ice from the administration standpoint,” Wall said. “I think that they are probably getting a lot of pushback from pharma in particular.”
With the slow pace of federal action on drug pricing, many states are exploring their own solutions, including importation, transparency, and price gouging bills. Several states, including California, Ohio, and South Dakota, have pushed for ballot initiatives, but after all 3 of those were defeated in recent years those efforts have slowed. Instead, advocates are working mostly on the legislative level, Gentile said.
ASHP has supported solutions such as manufacturers being required to provide the FDA with more information on the causes of drug shortages; establishing best practices for high-alert drugs; and increasing transparency from manufacturers.
Wall added that the ongoing tariff debates with China could affect the supply of active pharmaceutical ingredients (APIs). While there was an FDA proposition to allow for limited periods of importation when there is a lack of competition, she said there hasn’t been much development since that original proposal.
Regarding the push for expanded provider recognition, Gentile noted a trend of increased pressure from states to expand the scope of practice. A good state provider status law should include things like performing patient assessments, administering vaccines and immunizations, and managing drug therapy for chronic disease states, among other things, Gentile said.
Finally, ASHP maintains its stance that amendments to compounding legislation are unnecessary, said Huynh. He added that ASHP is generally supportive of the Drug Quality and Security Act, and continues to work with the FDA to ensure hospitals can continue compounding medications within their own systems. They anticipate an omnibus guidance on repackaging, biologics, and compounding in the near future.