Big Budget Boost for FDA
Posted: July 10, 2009
A report in yesterday's Wall Street Journal announced that the House has "overwhelmingly approved a $373 million budget increase for the Food and Drug Administration, the largest boost in the agency's history." In a vote of 266 to 160, the House approved a $2.99 billion budget for the agency in FY 2010. Of that, $349 million has been allocated for the Center for Devices and Radiological Health, placing it in the middle of the pack.
According to the Journal, which notes that the budget has been passed by a Senate committee but has yet to be voted by the chamber, the breakdown is as follows:
• $783 million for the Center for Food Safety and Applied nutrition.
• $873 million for the Center for Drug Evaluation and Research.
• $349 million for the Center for Devices and Radiological Health.
• $305 million for the Center for Biologics Evaluation and Research.
• $156 million for the Center for Veterinary Medicine.
The lion's share of the increase is headed toward the agency's beleaguered food arm, which faced a number of problems with food safety over the past year.
The is could be really good news for CDRH, which has often said that underfunding was at the root of many of its problems. Perhaps this boost will enable it to address problems more quickly and effectively.
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Sorry transposition
Sorry transposition error
Lots more money to OCI not OIC...
Office of Criminal Investigation
as in xxxx@oci.fda.gov
I woul dlove to see more
I woul dlove to see more money go to CDRH enforcement.
Why should our company go through all the time and effort to get the FDA to sign off on a product when others just say "the FDA never enforces anything, The FDA means nothing..."
FDA enforcement of the regulations will make getting an approval or cleance from the FDA worth a lot more if the cowboys and the scoff laws are purged from the market place...
I don't object to a level playing field but let's make really level...Everyone should obey the law...
More money to OIC for enforcement...
But wait! The average citizen
But wait! The average citizen does not know about the hefty fees the FDA charges for reviewing premarket product submissions (information about the product)for medical devices, drugs and biologics to get on the U.S. market. The review fee does not assure the product will be approved. And if the product is changed (after being on the market), the manufacturer must pay again if a submission is required.
This is tax payers' money which could go to much more needed programs. Good grief!
Maybe the agencies will be
Maybe the agencies will be able to physically visit international sites for audits instead of using third party auditors. This will mean stricter regulations of foreign sites.
Just what we need, more
Just what we need, more regulations to drive more biotech companies and clinical trials out of this country. The five to seven years and multimillion dollar budgets needed here to develop a minor change in a me-too drug or device has killed an entire industry. A new mechanism of drug delivery, for example liposomes, has taken over 30 years because all development is in foreign countries because overregulation, vexatious duplicative known safety factor repetitive studies, and arrogance of the entire regulatory bureaucrats is being enabled by more funding to this paramilitary organization.