Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection
Washington, D.C. (July 11, 2019) – BIO’s President and CEO Jim Greenwood issued the following statement after it was reported that the Trump administration is withdrawing its proposed rebate rule that would have required savings from drugmakers’ rebates be passed along to seniors enrolled in the Medicare drug benefit program:
“The administration has abandoned one of the only policy solutions that would have truly lowered what patients are forced to pay out of pocket for the medicines they need. This decision discards a proposal that would have also delivered meaningful transparency to an opaque system that puts the financial interests of middlemen ahead of the well-being of patients.
“It is deeply disappointing the administration succumbed to the same old scare tactics we see from the insurance industry whenever policymakers aim to address the discriminatory tactics insurers use against patients. The president has promised to rein in the role of middlemen and ensure patients directly benefit from the significant rebates biopharmaceutical companies provide, but today that promise was broken.
“This decision has dealt a blow to some of the most vulnerable patients, and it only heightens the urgency for Congress to adopt a reasonable cap on out-of-pocket costs for America’s seniors.”
Remarks by President Donald Trump, May 11, 2018:
- “We’re also increasing competition and reducing regulatory burdens so drugs can be gotten to the market quicker and cheaper. We’re very much eliminating the middlemen. The middlemen became very, very rich. Right? Whoever those middlemen were — and a lot of people never even figured it out — they’re rich. They won’t be so rich anymore.”
- “Our plan will end the dishonest double-dealing that allows the middleman to pocket rebates and discounts that should be passed on to consumers and patients.”
BIO is the world’s largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. BIOtechNOW is BIO’s blog chronicling “innovations transforming our world” and the BIO Newsletter is the organization’s bi-weekly email newsletter. Subscribe to the BIO Newsletter.