Senator Alexander and Representative Goodlatte Grill OMB on Proposed Generic Drug Labeling Rule

In the latest salvo fired over the controversial FDA proposed rule that would permit generic drug ANDA holders to unilaterally change their drug product warnings, Senator Lamar Alexander, Ranking Member, Committee on Health, Education, Labor & Pensions and Congressman, and Bob Goodlatte, Chairman of the Judiciary Committee asked the Office of Management and Budget’s Administrator of the Office of Information and Regulatory Affairs (OIRA) to explain a few things about the FDA position.

Where Do These Guys Come From?

In a series of FDA Safety Alerts, Recall Notices, and Enforcement Actions over the last couple of years, the Agency has notified consumers of dozens of OTC products that contain undeclared and dangerous drugs.