FDA Policy/General

Public Citizen Asks SCOTUS Not to Weaken FOIA

In a case that could have implications for FDA and many other federal agencies, the Supreme Court is being asked by the Food Marketing Institute to broaden one of the exemptions under the Freedom of Information Act (FOIA) so the government can refuse to disclose SNAP (formerly Food Stamp) program expenditure information to a newspaper reporter who filed a FOIA request. The Sioux Falls, SD, Argus Leader asked the U.S. Department of Agriculture (USDA) for several years of data showing how much it paid each year to businesses in the country that sell food under the SNAP program.

The newspaper says it believed the taxpayer payment information could identify potential instances of food stamp fraud as well as give insight into food deserts and food insecurity in rural South Dakota. When the department declined to release the data, citing a FOIA exemption for instances in which release of financial information would likely cause substantial competitive harm to a private business, the newspaper sued. In 2016, a federal judge wasn’t convinced that the exemption applied in this case and USDA agreed to release the data. Then the Food Marketing Institute (FMI), a trade and lobbying organization, appealed the decision, reportedly hoping that a potentially pro-business Supreme Court will diminish or even reject the “substantial competitive harm” standard that has been used in FOIA cases for decades.

In an amicus brief, Public Citizen, the Center for Science in the Public Interest, and the Collaboration for Research Integrity and Transparency argue that the current standard reflects Congress’ intent in passing FOIA. The three groups say that the limit on the exemption that has been recognized by courts for decades “is sensible and workable. The FMI’s contrary argument amounts to little more than a policy disagreement with Congress about the scope of exemption 4. The current construction of exemption 4 reflects the balance struck by Congress between disclosure and privacy; FMI’s alternative construction would result in an expansive exemption favoring broad withholding, contrary to FOIA’s purpose, as reiterated by this court.”

The Supreme Court heard oral arguments on the case 4/22.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome