GSK’s departure comes as the industry anticipates the incoming Trump administration and as it continues to grapple with the threat of the BIOSECURE Act and losses of legal challenges to the IRA’s drug price negotiation program.
GSK will not renew its membership with leading industry lobby group Biotechnology Innovation Organization, according to several media reports on Friday.
“At this time, we believe there are other areas we can focus our resources,” a GSK spokesperson in a statement to Fierce Pharma. “We remain committed to fostering a policy environment that prioritizes disease prevention, addresses health equity and access barriers, and incentivizes sustainable innovation.”
BIO has suffered several high-profile departures over the past year. In April 2024, Japanese pharma Takeda likewise revealed that it had not renewed its membership with the organization for its 2024 fiscal year, outlets reported at the time. That move followed similar ones by UCB and AbbVie.
And in December 2023, STAT also reported that pharma powerhouse Pfizer would be parting ways with BIO. In a statement at the time, the trade group’s chief public affairs and marketing officer Rich Masters said that the organization was “disappointed” by the departure, which he attributed to economic reasons. “But it in no way affects our mission of protecting patients and medical innovation in the United States.”
Perhaps most well-publicized of recent exits, however, is WuXi AppTec, which in March 2024 announced that it would cut ties with the lobby group over tensions surrounding the BIOSECURE Act.
GSK’s departure from BIO comes as the industry faces an uncertain future under the incoming Trump administration. Analysts see Trump’s election win as a modest positive for pharma, with a potentially more industry-friendly Federal Trade Commission (FTC) that is more lenient toward acquisitions and other transactions. However, this optimism is largely offset by the possibility of having Robert F. Kennedy hold a leadership role in the Department of Health and Human Services—including the FDA and CDC.
GSK’s BIO exit also coincides with the industry’s struggle to gain legal footing against the drug price negotiation program of the Inflation Reduction Act (IRA). The companies’ arguments touch on two main arguments of unconstitutionality—that the negotiations constitute the unlawful taking of their products without just compensation, thus violating the Fifth Amendment, and force them to parrot government talking points, in breach of the First Amendment.
Courts have largely been skeptical. In April 2024, New Jersey Judge Zahid Quraishi ruled against Johnson & Johnson and Bristol Myers Squibb. The judge also handed Novartis a similar defeat last month. In July 2024, Boehringer Ingelheim likewise lost its case against the IRA negotiations, as did industry group Pharmaceutical Research and Manufacturers of America (PhRMA) in February 2024.
These cases are in several stages of appeals. In September 2023, the Fifth Circuit Court of Appeals took PhRMA’s side and sent the case back to a lower Texas court, which will hear the merits of the group’s case against the IRA. Last week, the Third Circuit Court of Appeals heard arguments from AstraZeneca, J&J and BMS—though the three-judge panel did not indicate which way they leaned.
It is yet unclear how the Trump administration will affect the IRA, though analysts believe that the price negotiations could be revised or deprioritized.
BioSpace has reached out to both GSK and BIO and will update this article with new information as they become available.
