Growing Pains at BIO as Price Control Debate Heats Up in Washington and Within the Industry

In January, Dr. Michelle McMurry-Heath, chief executive officer of Biotechnology Innovation Organization (BIO), reorganized the leadership structure of the trade group to provide what was expected to be “long-term stability for the organization.” However, recent reports have suggested that stability has not been achieved.

Multiple reports from STAT News suggest an exodus of team members, particularly lobbyists tasked with meeting Congressional and state legislators' leadership. Much of the turmoil centers on drug-pricing policy, which has been a hot-button issue in the pharmaceutical industry for years. According to the STAT report, a number of pharmaceutical executives have been pushing the organization to support calls for drug-pricing controls, particularly regarding Medicare, while another segment has been adamantly opposed. Those executives opposed to pricing controls have argued that the industry would be negotiating against itself.

When McMurry-Heath announced the reorganization in January, she said the plan would support BIO’s goals of advocacy, education and collaboration. The agency has placed its leadership vision on five different pillars: Be a voice of science and for science, unite and empower biotech innovators and their ecosystem to improve lives, remove barriers to innovation, champion broad access to biotech breakthroughs and scientific equality, and catalyze resilient and sustainable bio-based economies.

While some of BIO’s members have championed drug-pricing controls, the organization has expressed uncertainty about plans promoted by the Biden administration. In August, Rich Masters, BIO’s chief public affairs and advocacy officer, called the Biden plan “the wrong approach.” Masters said it would ultimately restrict access to critical medicines and negatively impact small, innovative biotech companies seeking capital needed to discover new medicines. Masters maintained the industry stance that the plan allowing Medicare to negotiate prices will create new barriers for medical innovation.

 “BIO has made clear our desire to advocate for policy reforms that lower patient spending at the pharmacy counter without compromising scientific advancement and the support needed to usher in the next generation of cures and breakthrough medicines. Unfortunately, the president’s plan is no such reform,” Masters said in a statement.

Masters' comments regarding disruption to innovation echo similar concerns raised by other industry leaders and advocacy organizations. Last week, an analysis released by the nonpartisan Congressional Budget Office (CBO) supported the idea that an overhaul of Medicare that includes the ability to negotiate prices would hinder long-term innovation. The CBO analysis estimates the policy in HR3, which was passed by the U.S. House of Representatives and supported by the administration, will lead to two fewer drugs in the first decade, 23 fewer over the next decade, and 34 fewer drugs in the third decade.

While there may be some growing pains within BIO, the organization has come out in support of the seventh renewal of the Prescription Drug User Fee Act (PDUFA). BIO said PDUFA “continues to enhance and strengthen” the U.S. Food and Drug Administration (FDA) by “fulfilling its public health mission and ensure that safe, effective, and high-quality new drugs and biological products are reviewed in an efficient and predictable time frame.” BIO went on to say the reauthorization will strengthen scientific dialogue between the industry and the regulatory agency.