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Worries About 180-Day Exclusivity Reforms Persist As User Fee Bill Advances
FDA-crafted legislative text emerges that generic industry says could weaken the incentive, but so far no changes are in the draft House and Senate bills.

Copay Assistance Can Be Excluded From Medicaid ‘Best Price’ Without Strings Attached – US Court
Decision is a win for the Pharmaceutical Research and Manufacturers of America in lawsuit against the US Health and Human Services Department.

PK Evaluation In Pregnancy: Can HIV Show A Way Forward?
US FDA workshop on efforts to advance pharmacokinetic data collection in pregnant women highlights the (slow-moving) antiretroviral experience, but COVID therapies show that regulatory receptiveness is a poor match for recruitment and liability concerns.

At Solicitor General’s Urging, Supreme Court May Take Up Patent Eligibility Dispute Riling Biopharma
Federal Circuit’s rulings on subject matter patent eligibility have fractured the court, the US government says in advising the high court to review American Axle v. Neapco to provide clarity. BIO, former PTO director Kappos and Sen. Tillis also urge Supreme Court to hear the case.

FTC And PBMs: Support For Investigation Building But Outcome May Ultimately Disappoint Critics
Federal Trade Commission’s ‘pro-competitive’ perspective could support conclusion that pharmacy benefit managers serve useful role in lowering drug costs, health policy expert suggests. FTC will get an earful about PBM practices, but ‘those complaints could be an indication that competition is working.’

Inter-Agency User Fees? US FDA/ARPA-H Relationship Could Get Interesting
The Biden Administration’s signature health research agency ARPA-H is still in the formative stages. Authorizing legislation moving through Congress could set up a very interesting dynamic when it comes to working with the US FDA.

Surprise US FDA Facility Inspections Resume In India
Unannounced facility visits also were to start again in China, but FDA Commissioner Robert Califf said they have been delayed by the COVID-19 outbreak in the country.

House GOP Targets US FDA Applications With China-Only Data, Cites General Oversight Concerns
While industry concern with FDA’s policy shift on clinical data from China has focused on the disruption in business plans, Republican lawmakers appear to feel that the agency has not gone far enough and are seeking a GAO review of FDA’s entire bioresearch monitoring program.

US FDA To Explore New Regulatory Pathways For Some Cellular Products
Agency re-evaluating criteria for certain human cells, tissues and cellular and tissue-based products (HCT/Ps) that are not ideally regulated as BLAs; industry suggests a 2014 guidance which created an alternative pathway for cord blood products could serve as potential template.

US FDA Supply Chain Guidance Includes More Stakeholders, More Risks Than CARES Act
Draft guidance on redundancy risk management plans layers risk-based expectations over new statutory requirements to plan more resilient supply chains for critical drugs.

Senate Commerce Leaders Want An FTC Study Into PBM Business Practices – And More
Committee Chair Maria Cantwell (D-Wash.) solicits advice from witnesses for additional authorities to conduct oversight of PBMs and pushes for a GAO study.

Inhaler Changes For Environmental Reasons Worry Generic Sponsors, Prompt Call For FDA Research
ANDA sponsors say eliminating the HFC propellant, while important to help address climate change, could upend the generic market without guidance from the US FDA.
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