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Ranitidine Cancer Risk Found Only By Litigation Plaintiffs’ ‘Unreliable’ Research, Judge Rules

 
• By Lauren Nardella

 Plaintiffs in Multi-District Litigation didn’t provide scientific evidence of OTC heartburn drug Zantac increasing risk of cancer. Federal judge says plaintiffs' research showed “a lack of substantiation for analytical leaps” in alleging dangerously high levels of NDMA in ranitidine drugs.

• Source: Shutterstock

The initial research sparking concern about a potential link between heartburn drug ranitidine and cancer and additional studies noted in thousands of complaints for damages from manufacturers were faulty and unreliable, a federal judge says.

In US District Court for Southern District of Florida, Judge Robin Rosenberg in a summary judgement dismissed all Multi-District Litigation against numerous firms with links to Zantac and other OTC...

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Loper Bright ‘Might Not Be Cataclysmic’ With FDA’s ‘Good Reputation’ For Science – Attorney

 
• By Malcolm Spicer

Bridget Dooling, law school professor who reviewed draft regulations from FDA and other agencies as OMB attorney, says history of federal court decisions in litigation challenging FDA’s interpretation of statutes points to judges typically defer to agency decisions based in science.

Supreme Court 1935 Ruling Limiting Executive Authority On Appointments ‘Unravels’ Today – DoJ

 
• By Malcolm Spicer

In complaint and response to motion to dismiss, Rebecca Kelly Slaughter’s and Alvaro Bedoya’s attorneys elaborate on Supreme Court ‘s 1935 decision, Humphrey’s Executor v. US. Administration attorneys, though, contend the ruling isn’t relevant to the current FTC.

Congress, Researchers Highlight Security Risks At DNA Testing Services

 
• By Elizabeth Orr

Congress launched an inquiry into 23andMe amid privacy concerns following its bankruptcy, particularly regarding the potential sale of sensitive user data. Additionally, a Cybernews report gave 40 DNA testing firms an average cybersecurity grade of D, citing widespread vulnerabilities and data breaches, along with inadequate public information about their security practices.

Xlear Sees Tip Of FTC Policy Iceberg In DoJ Dismissal Of False Advertising Complaint

 
• By Malcolm Spicer

It wasn’t a quick decision for Xlear to accept DoJ attorneys’ offer to dismiss the case. “I want the I want the FTC to change its policy and its behaviors,” says Xlear president Nathan Jones.

More from Policy & Regulation

Haleon Study: Boosting Health Literacy Could Save Major Economies Over $300bn Per Year

 
• By David Ridley

By addressing disparities in health literacy, particularly in the areas of oral care, bone health, nutrition and air pollution, the consumer health industry can “save lives and billions in healthcare costs, boosting productivity and increasing GDP,” says a new report from Haleon and Economist Impact.

Over The Counter: Taking Real-World Evidence Seriously, With IQVIA Consumer Health’s Volker Spitzer

 
• By David Ridley

In part 2 of HBW Insight's interview, IQVIA Consumer Health's vice president of global research and development and real-world evidence services, Volker Spitzer, explains how to approach real world evidence so that regulators recognize its validity, in supporting Rx-to-OTC switch applications, for example.

US FDA Expands Surprise Foreign Inspections

 
• By Sue Sutter

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.