Washington Drug Letter

An industry effort to protect user fees from sequestration got a major boost June 13 as House leaders vowed to take up the issue in future budget negotiations with the Senate.

U.S. District Judge Edward Korman has agreed the government’s proposal to approve a new sNDA for Teva’s Plan B One-Step without age or point-of-sale restrictions satisfies his April 5 order. However, he argued against the FDA granting Teva any period of market exclusivity that would delay access to generic versions.

The FDA is seeking industry comment on the litany of requirements for submitting BLAs, to gauge how burdensome the requirements are and if they can be streamlined.

Drugmakers’ shortage-prevention programs aren’t catching quality deviations as designed, according to a new survey that paints a stark picture of shortage prevalence.

The FDA June 12 published a list of proposed “qualified pathogens” it believes most endanger the public and might be eligible for qualified infectious disease product (QIDP) designation under the GAIN Act provisions of the FDA Safety and Innovation Act (FDASIA).

The FDA has finalized changes to orphan drug regulations, clarifying confusion around orphan drug designation and the terms that have hung up sponsors of rare-disease treatments.

State-level efforts to hinder substitution of biosimilar interchangeable products are premature and unfounded, a U.S. pharmacist group says, as Oregon and Delaware join a growing list of states moving to advance legislation that restricts the substitution of biosimilars for brand biologics.

The FDA rapped Janssen for making unproven efficacy claims about its ovarian cancer drug Doxil on its website.

Problems handling mold and defects at two plants sparked an FDA request for Baxter International to take a hard look at its global manufacturing operations.

The Supreme Court June 13 dismissed Myriad Genetics’ patent-eligibility claims on the BRCA1 and BRCA2 genes commonly associated with breast and ovarian cancers, while upholding the company’s patents on the diagnostic technology it created from those genes.

The FDA slammed drug and active pharmaceutical ingredient (API) maker RPG Life Sciences for deleting and backdating records and lacking a “robust quality system.”

Drugmakers used comments to an FDA draft guidance on formal agency meetings for biosimilars to push for clarity on biosimilar user fees, with one company, Mylan, arguing the fees should be lower than those paid for drugs beholden to PDUFA requirements.

Teva has reached a $2.15 billion settlement with Pfizer to resolve a long-running patent fight related to Pfizer’s acid reflux drug Protonix that had recently not been going in Teva’s favor.

An injector’s intended use, technical characteristics and proposed labeling and packaging can mean the difference between filing a marketing submission with CDER, CBER or CDRH.