The Federal Trade Commission hopes to target drug patent settlement agreements involving authorized generics, saying in a federal court brief this week that such agreements are anticompetitive under a recent key appeals court ruling expected to trigger Supreme Court review on the topic. The agency's view conflicts with companies who assert that the ruling only applies to reverse monetary payments between companies. FTC said settlements involving authorized generics became more prevalent once the agency pursued cash settlements.1348 words

A duo of Democratic lawmakers and backers of device predicate nullification measures during debate around the FDA Safety and Innovation Act, pressed FDA this week to make changes to its 510(k) device database that would provide more information about products recalled for serious design flaws, saying the updates could help manufacturers avoid using recalled devices as predicates.627 words

The National Health Council has been meeting with FDA on proposals for implementing FDA Safety and Innovation Act provisions intended to provide a structured framework for including input from patients and patient organizations throughout the agency's decision-making process. The group, which represents close to 50 different patient organizations, is pushing FDA to distinguish between input from consumers, patients and organizations that represent them, and where each group should be factored in during the drug development process.1003 words

New draft guidance outlining FDA's refuse to accept policy for 510(k) medical device submissions could lead the agency to invoke its authority to block incomplete applications more frequently and encourage companies to submit more complete submissions, a change that could speed up review times, industry attorneys said following release of the user fee-mandated guidance. But, attorneys also said a new 15-day review period prior to the start of the official time clock could also drag out timelines for sponsors as FDA does not specify how many times the agency and sponsors can cycle through the 15-day completeness check, industry attorneys said.1014 words

The U.S. Court of Appeals for the Federal Circuit Thursday (Aug. 16) reasserted that isolated DNA is patent eligible in a case that has broad implications for the biotechnology industry and was reconsidered by the appeals court following a recent landmark Supreme Court personalized medicine decision. The court said Congress should weigh in on the matter if longstanding industry and Patent and Trademark Office practices are to be changed.716 words

A recent court order for FDA to complete withdrawal hearings for two classes of antibiotics used in food producing animals within five years outlines a rare judicial intrusion on the "inner workings of an agency," but could factor into other pending cases where stakeholders seek FDA action, including enforcement related to the controversial preterm labor drug Makena, according to an attorney. A public health advocate said the withdrawals will be lengthy, making it possible that FDA could tackle it in tandem with its new antibiotic policies that focus on label changes and increased veterinary oversight.661 words

A group of mostly Democratic senators pushed FDA this week to take a stronger stance on animal antibiotic prevention uses, saying continued use of antibiotics for prevention purposes could weaken the impact of the agency's new policies recently outlined in guidance and regulation. The lawmakers, which include key appropriators, also pressed the agency to design a system to gather and analyze information to assess the effectiveness of these new policies.600 words

Two medical professors said they are worried about the potential for industry influence in the voluntary prescriber training component of FDA's recently finalized Risk Evaluation and Mitigation Strategy for certain opioids, with the researchers laying out their concerns in a recent Journal of American Medical Association article. Industry and continuing medical education sources roundly dismissed the notion, saying FDA established and CME providers maintain clear barriers between the training and industry influence.1157 words

A food safety advocate and an industry stakeholder are praising FDA's recently released draft guidance creating more food registration categories, such as acidified fish and infant formula, with the stakeholders saying the changes could help the agency during outbreaks and recalls, and determine where to target inspection resources. However, a state food official said questions remain about how FDA will coordinate federal food registrations with similar requirements at the state level.770 words

Updated heparin quality control specifications being finalized by FDA and U.S. Pharmacopeial Convention will help companies better detect contamination in the blood-thinner that resulted in patient deaths and prompted drug supply chain reform in the recently passed FDA Safety and Innovation Act, USP and FDA officials said at heparin workshop this week. FDA and the standards setting body are also updating labeling for heparin products following concerns with improper dosing resulting from current labeling that was not in compliance with USP standards.621 words

A group of industry, academic and patient advocacy stakeholders hope a new report on obesity drug development tools, including suggestions on how to limit the inappropriate use of these drugs and characterize their risks, will affect FDA's consideration of obesity treatments and be incorporated in final guidance on the issue. The report, published by George Washington University, said the recommendations, which largely focus on how to improve the quality of life for obese patients, could be bolstered by a mandate in the FDA Safety and Innovation Act for the agency to consider patient perspectives during regulatory discussions. However, a consumer safety advocate questioned the premise of the report and the ability to prevent misuse of the drugs.1236 words

Sen. Chuck Grassley (R-IA) is expanding his investigation into government use of employee monitoring software, asking the Drug Enforcement Administration in a letter this week whether the agency used software similar to the program FDA used to monitor its staff.277 words

CMS announced on Monday (August 13) that it is immediately discontinuing a hospital quality reporting measure used in determining whether hospitals properly care for heart-attack patients after FDA recalled devices that many hospitals were using to monitor compliance with the measure.351 words

Federal agencies will have to test their data collection forms before releasing them to the public, according to a new requirement from the White House Office of Information & Regulatory Affairs (OIRA). Among the types of forms that the Office of Management and Budgetlists as examples are forms for obtaining grants, and the new requirement also likely includes information collection requests (ICRs).448 words

The U.S. District Court for the Northern District of Georgia said last week that the Georgia Department of Community Health must cease prior authorization procedures that favor compounded versions of the preterm labor drug Makena over the branded drug. The preliminary injunction decision marks the first favorable ruling for drug manufacturer KV Pharmaceutical since filing three lawsuits in recent weeks targeting FDA and state Medicaid reimbursement policies that the company says have hindered access to its drug.735 words