Policy
Albert Bourla confirmed that he called President Donald Trump after receiving a letter asking Pfizer and a clutch of other pharmaceutical companies to lower drug prices or face consequences.
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In a recent interview, FDA Commissioner Marty Makary said there “should be nothing political about the FDA.” Recent actions taken by HHS Secretary Robert F. Kennedy, Jr. and others within the department appear to be at odds with this sentiment.
As Marty Makary nears the end of his first month on the job, the FDA Commissioner sat down for two interviews, offering statements that alternatively contradict and jibe with reported events.
FDA Commissioner Marty Makary last week announced a directive that would limit industry participation in the agency’s advisory committees. But not only do company reps serve only as non-voting members, a 1997 law actually requires industry involvement.
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At a satellite kickoff event to the annual BIO meeting, investment bankers and VCs gave reasons for optimism amid a ‘volatile’ period for the industry.
Scientists and analysts express concern that the newly appointed ACIP members—which include known anti-vaxxers—could relitigate recommendations that have already been made. Many are imploring Sen. Bill Cassidy to step up.
The rehired staff, who number around 460, work with the CDC’s viral disease prevention efforts and sexual health testing labs, among others. The reinstatements are a ray of light in an acrimonious week that also saw protests and the complete overhaul of the agency’s vaccine advisory committee.
The eight new committee members replace the 17 Kennedy removed earlier this week. In “repopulating” the committee, the HHS Secretary fulfilled the fears of some analysts, naming scientists who appear to reflect his anti-vaccine views.
The American Medical Association is also urging an “immediate reversal” of the HHS Secretary’s decision to oust all 17 members of the CDC’s vaccine advisory board.
Gene therapies have ridden investor mania to huge valuations but commercialization challenges have pushed market caps to the floor. At a roundtable last week, FDA leaders promised faster approvals and broad support to the industry.
Robert F. Kennedy Jr.’s removal of all remaining members of the CDC’s Advisory Committee on Immunization Practices raises questions about the upcoming meeting later this month. Analysts fear the committee could be more sympathetic to the HHS Secretary’s anti-vax viewpoints.
The reinstatement of the generic drug policy office is the latest reversal of course for Robert F. Kennedy Jr.'s HHS, which also recently rehired FDA staff responsible for making travel arrangements and those involved in user fee program negotiations.
Two weeks of upheaval at the CDC culminated Monday in the complete reconstitution of the CDC’s Advisory Committee on Immunization Practices as HHS Secretary Robert F. Kennedy Jr. pens op-ed criticizing “conflicts of interest” he says exist on the current committee.
The loss of special government employee status for four members of the CDC’s Advisory Committee on Immunization Practices follows the resignation of ACIP co-lead Lakshmi Panagiotakopoulos, who left in protest of a controversial change in COVID-19 recommendations for healthy children and pregnant women.