Rx Drugs

FDA warned domestic and foreign drug makers that beginning Sept. 12 it will inactivate drug listings in the National Drug Code (NDC) directory that haven’t been recently updated or certified or that include an establishment with an expired registration.

FDA will hold a public meeting on Nov. 7 to solicit ideas on ways to improve the drug development process, including through new trial designs such as master protocols that could cross multiple therapeutic areas and be implemented in the near term, the agency announced Friday (Aug. 9).

Brand drug makers’ return to price hikes this year helped CVS Health’s pharmacy benefit manager make a lot more money from rebates in the second quarter of this year than Wall Street expected, according to the company’s second quarter earnings report.

Some generic drug stakeholders told Congress’ oversight arm that brand-drug makers are strategically timing labeling changes as a ploy to stall generic drug competition.

Senate Finance Committee Chair Chuck Grassley (R-IA) is pressing FDA to resume surprise inspections of foreign drug manufacturing facilities as part of the administration’s newly unveiled plan to allow prescription drug imports.

Hospitals that administer the expensive new CAR-T gene therapy are not required to participate in a clinical registry or study aimed at determining whether real-world results mirror those from clinical trials used to get the cancer drugs approved, according to the national coverage determination CMS published Wednesday (Aug. 7).

The majority of postmarketing requirements and postmarketing commitment studies for fiscal 2018 were successfully completed by industry or are on their way to being completed on time, with few studies delayed, Acting FDA Commissioner Ned Sharpless said Tuesday (Aug. 6).

CMS will increase the add-on payments hospitals receive for CAR-T cancer treatments, but the agency didn’t make what industry sources say are easy changes to the reimbursement system that would have allowed CMS to know the true price of chimeric antigen receptor T-cells.

AARP spent at least $700,000 on prescription drug pricing-related television ads in five states that span the territory of Senate Majority Leader Mitch McConnell and of a handful of GOP senators who face competitive 2020 re-election races.