Drug Pricing

Pfizer announced Thursday (June 22) that FDA has rejected its epoetin alfa biosimilar due to good manufacturing practice violations, despite an advisory committee recommending approval last month.

FDA isn't waiting for the generic drug user fee reauthorization measure to move through Congress to move forward with one of the package's commitments: A new draft guidance issued this week sets up a new pre-submission process for certain generic drug applications, which FDA chief Scott Gottlieb says could cut two months off review times and increase access to affordable drugs.

FDA will create a “Medical Innovation Development Plan” aimed at lowering health care costs by facilitating development of drugs to treat costly rare diseases through improved adaptive trial designs and statistical tools, agency chief Scott Gottlieb announced Tuesday (June 20).

The U.S. Supreme Court agreed last week take up a case that will determine the constitutionality of the patent office’s inter partes review process -- an administrative procedure for challenging patents that some drug industry stakeholders have said undermines the drug pipeline and unfairly uses a lower standard for reviewing patents than that used by a district court.

President Donald Trump could use an executive order to direct the CMS innovation center to waive rules that would make it easier for drug companies and insurance companies to use value-based contracts, said Paul Howard, director and senior fellow at the Manhattan Institute.

Academics and policy experts said that value-based contracts, real-world evidence and drug repurposing for off-patent and on-patent drugs could help to spur competition and lower drug prices.

Senate health committee Chair Lamar Alexander (R-TN) plans to hold a second drug-pricing hearing in July that will examine how the drug development and approval process affects the cost of prescription drugs.

CMS, FDA and the Health Resources and Services Administration are developing recommendations for lowering drug prices, HHS Secretary Tom Price said Thursday (June 8), and providers worry the Part B drug price demonstration proposal might still be on the table, despite that the Obama administration deserted the idea in the face of opposition from drug makers, patients and cancer doctors.

A new analysis from Matrix Global Advisors finds that 74 drugs with total sales of $22.7 billion are subject to either an FDA-mandated Risk Evaluation and Mitigation Strategies (REMS) program with restricted distribution, or a self-imposed restricted distribution system.