- So Much More than Just Paperwork – The Importance of Design Controls for Device Start-ups February 7, 2023
- Good Things Came in Threes for These Drug Companies: Three Judges at the Third Circuit Found for Three Drug Makers in 340B Contract Pharmacy Case February 5, 2023
- Separating the Hype from the Hyperbole Surrounding FDORA’s Alternatives to Animal Testing under the FD&C Act February 3, 2023
- Eleventh Circuit’s Decision is Not a Catalyst For Change February 1, 2023
- The Orphan Drug Act Almost Failed to Clear the Launch Pad Before Achieving so Much for Patients! January 31, 2023
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Supreme Court Limits Court Review of Government’s Change of Policy
April 28, 2009By John R. Fleder –
On April 28, 2009, the United States Supreme Court issued an important ruling on an administrative law issue. In FCC v. Fox Television Stations, the Court by a 5-4 vote ruled that the FCC had properly explained its decision that Fox had allowed "indecent" language to appear on two live broadcast incidents where performers (Cher, Nicole Richie, and Paris Hilton) uttered alleged obscenities. The Second Circuit Court of Appeals had earlier reversed the FCC's decision when that court concluded that when an agency changes its policy on a matter, the agency must give a "more substantial explanation" for its new policy. The Supreme Court reversed and concluded: "[w]e find no basis in the Administrative Procedure Act or in our opinions for a requirement that all agency change be subjected to more searching review." Instead, the Court stated that an agency should ordinarily acknowledge that it is changing its position and that there are good reasons for the new policy. However, according to the Supreme Court, the agency need not demonstrate to a court's satisfaction that the reasons for the new policy are better than the reasons for the old one.
One can safely assume that the new Obama Administration will cite this ruling whenever it chooses to alter a policy developed in the prior Administrations.
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- So Much More than Just Paperwork – The Importance of Design Controls for Device Start-ups February 7, 2023
- Good Things Came in Threes for These Drug Companies: Three Judges at the Third Circuit Found for Three Drug Makers in 340B Contract Pharmacy Case February 5, 2023
- Separating the Hype from the Hyperbole Surrounding FDORA’s Alternatives to Animal Testing under the FD&C Act February 3, 2023
- Eleventh Circuit’s Decision is Not a Catalyst For Change February 1, 2023
- The Orphan Drug Act Almost Failed to Clear the Launch Pad Before Achieving so Much for Patients! January 31, 2023
- 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