Hamburg: FDA needs funding to hit inspection goal

Facing a House Appropriations Committee during an axe-sharpening session, FDA commissioner Margaret Hamburg stood her ground last week over the agency's $4.3 billion funding request. "If we don't get the money, we will...not be able to fulfill the very ambitious [manufacturing plant] inspection mandate, domestically and internationally."

President Obama's budget indicates about a 30 percent increase for FY 2012. The funding request, compared to flat budget requests for many agencies, reflects his desire for an FDA technology and regulatory-science makeover.

However, since assuming control of the House, Republicans have been eyeing the regulator's budget and have suggested cuts of $400 million already. Yet the inspection mandate came last fall from the Government Accountability Office, which works for Congress.

Also during the hearing, members reviewed the agency's handling of oxycodone abuse and the outsourcing of ingredient production for drugs such as Heparin to other countries.

- here's a summary from ABC
- see Food Safety Newstake
- here's more from C-SPAN
- and more

Suggested Articles

Recipharm has been building its capabilities in sterile injectable and inhalation drugs. Now it is buying a CDMO that manufactures devices for both.

The FDA has slapped the parent of Dollar Tree stores with a warning letter saying some CMOs that made its OTC products were among the world's worst.

GSK expects Shingrix supplies to rise slightly in 2020, but the real "step change" will come in 2024 with a brand-new manufacturing facility.