Assuming the helm as FDA Commissioner in May 2017, Scott Gottlieb has blasted brand manufacturer “shenanigans” for blocking generic-drug development and cited “pernicious” rebating schemes that expose consumers to high out-of-pocket costs for medicines.
That’s not all. To help mitigate the nation’s deadly prescription drug epidemic, he has backed policies to reduce opioid prescribing and to develop less addictive pain treatments.
Finally, Gottieb has promoted innovative clinical research methods and other strategies to make drug testing more efficient. There’s probably more in the making since all details directly relating to pharmacies has not be revealed.
What does all this means to pharmacists? All of the Commissioner’s actions…if they materialize…will have impacts on pharmacists. Although complete details directly related to pharmacists have not been revealed, pharmacists can expect the consequences to be financially detrimental…if proposed prescription drug costs are reduced. Pharmacists can expected to be “challenged” to undertake initiatives to curb excessive utilization, including reducing our nation’s prescription drug epidemic.
A clear achievement to the Commissioner’s proposals includes a $400-million boost in the FDA’s budget for 2019, as compared to the administration’s plan to cut the agency’s appropriations by $700 million a year ago. “This dramatic swing of over $1-trillion can only result in changes at the pharmacy counter, and pharmacists will be among the key provider expected to accomplish those changes…as they have in previous years,” said WVPA Executive Director Richard Stevens.
Several initiatives advance the testing and production of new therapies, including greater use of real-world evidence and knowledge management systems to facilitate regulatory decisions, particularly for new treatments for rare diseases. FDA also highlights the importance of modernizing drug manufacturing in proposing to spend $35 million to produce novel technologies, vaccines, and personalized medicines more reliably and at lower costs.
Of interests to many pharmacists, Gottlieb has urged shifting from an egg-based to cellular system for seasonal flu vaccines, along with efforts to develop universal influenza vaccine to provide multi-year protection, and ensure US access to vaccines to protect against a pandemic. He emphasized the importance of promoting vaccination rates, despite continued opposition from vaccine deniers.
The FDA faces numerous deadlines for implementing key provisions of the 21st Century Cures legislation, including policies to support regenerative medicine and to speed the development of new cancer therapies, personalized medicines, and gene therapies. At the other end of the spectrum is a press for more efficient oversight and approval of over-the-counter medicines through a new user-fee program.
Combating the opioid epidemic is a prime challenge. While FDA supports the development of safer and more effective pain therapies and treatments for substance abuse and is re-examining the safety of abuse-resistant products, physicians are pushing back on proposals to limit opioid prescribing.
New legislation may strengthen the FDA’s authority to require small-dose packaging of opioids…a function expected to be required of pharmacists…and to remove from the market approved pain medicines found to raise safety issues.
Gottlieb plans to remain a visible advocate for lower drug prices, anticipating a continued roll-out of incremental changes to create a more competitive prescription drug market place. He has loudly criticized drug reimbursement (rebates) and coverage policies for limiting consumer access to drugs, including a “rigged payment scheme” that blocks biosimilars, and suggested that FDA may be more flexible in setting standards for flexible insetting standards for demonstrating product interchangeability.
The Commissioner’s concerns about the high cost of medicines reflect his own personal experience as a physician and seeing ill patients “struggling very hard at the worst moments in their lives” to try to afford drugs that are “absolutely indicated for their disease.” He wants to be sure “that in my time here at FDA, I do something to address that.”
(Sources for this WVPA News is attributed to Pharmaceutical Technology May 2018 PharmTech.com)