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With Draft Food Safety Legislation, Heavy Burdens All Around
June 11, 2009By Ricardo Carvajal –
Much ink has already been spilled detailing the burdens that draft federal food safety legislation would impose on industry (click here for the latest version of the Food Safety Enhancement Act of 2009 (“FSEA”)). Little has yet been said about the burdens that the legislation would impose on FDA. A quick tally suggests that FDA would be required to issue or amend six regulations, and perhaps as many as ten (some provisions give FDA the option of issuing a guidance document instead of a regulation). FDA would be given discretionary authority to issue or amend four additional regulations (perhaps as many as eight). In addition, the legislation would impose continuing reporting requirements on FDA in several areas. All of these burdens are in addition to those that would result from the aggressive inspection schedule that the legislation would impose on the agency.
The draft legislation’s rulemaking and other requirements would surely soak up substantial resources within FDA. To gauge their potential impact, one need look no further back than 2002, when the rulemaking requirements associated with the Bioterrorism Act appeared to derail a number of the agency’s other food-related initiatives. Even with substantial increases in funding, a similar outcome seems likely if FSEA passes in anything resembling its current form.
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- GAO Report on Clinical Research Inspections Encourages FDA to Care for its Clinical Inspection Program March 29, 2024
- FTC Continues to Rage Against Device Patent Listings in the Orange Book March 27, 2024
- FDA Approval of New Therapy, Duvyzat, for Duchenne Muscular Dystrophy Represents Several Meaningful Firsts March 26, 2024
- Arkansas Law Prohibiting Manufacturer 340B Contract Pharmacy Restrictions Upheld by 8th Circuit March 25, 2024
- Conference Notebook: ACI’s Cosmetics and Personal Care Products Conference March 22, 2024
- Big Molecule Watch Blog
- Bloomberg BNA Health Care Blog
- Drug and Device Law Blog
- Eye on FDA
- FDA Matters
- Harvard Law Bill of Health
- IN VIVO Blog
- Internet Drug News.com
- Lachman Consultants Blog
- Medical Devices Today
- Orange Book Blog
- The Orange Book Insights Blog
- Pharma IQ
- Pharmalot
- SCOTUS Blog
- The Volokh Conspiracy
- WLF Legal Pulse
- Advertising and Promotion (Federal Trade Commission)
- Advertising and Promotion (OPDP)
- Animal Drugs and Feeds
- Biosimilars
- Cannabis
- cGMP Compliance
- Consumer Product Safety Commission
- Controlled Substances
- Cosmetics
- COVID19
- Current Affairs
- Dietary Supplements
- Drug Development
- Drug Enforcement Administration
- Enforcement
- FDA News
- Foods
- Foods and Dietary Supplements
- Fraud and Abuse
- Government Pricing
- Hatch-Waxman
- Health Care
- Health Privacy
- Import/Export
- In Vitro Diagnostic Devices
- Jobs
- Medical Devices
- Miscellaneous
- Orphan Drugs
- OTC Drugs and Cosmetics
- Prescription Drugs and Biologics
- Product Jurisdiction and Combination Products
- Reimbursement
- Tissue Products
- Tobacco
- Uncategorized