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Daily Briefing

Around the nation: Generic versions of Viagra and Cialis may be unsafe, ineffective


FDA has alerted drugmakers about falsified data regarding generic versions of Viagra and Cialis, calling into question their safety and efficacy, in today's bite-sized hospital and health industry news from the District of Columbia and Maryland.

  • District of Columbia: HHS last month published a new final rule that prohibits healthcare providers from blocking authorized users from accessing EHR data. According to Modern Healthcare, the regulation to prevent information blocking originated from the 21st Century Cures Act of 2016 and applies to providers such as hospitals, physicians, and accountable care organizations. If HHS determines that a provider knowingly prevented others from appropriate use of EHR data, they will be subject to Medicare reimbursement cuts. Last July, HHS' Office of Inspector General also introduced similar regulation that would fine technology companies and health information exchanges that block information up to $1 million. "With this action, HHS is taking a critical step toward a healthcare system where people and their health providers have access to their electronic health information," said HHS Secretary Xavier Becerra in a news release. “When health information can be appropriately accessed and exchanged, care is more coordinated and efficient, allowing the healthcare system to better serve patients." (Early, Modern Healthcare, 6/24)
  • Maryland: According to a Bloomberg analysis, generic versions of Viagra, Cialis, and other medications may have been allowed on the US market using data from potentially problematic studies — a finding that calls into question their safety and efficacy. In June, FDA alerted brand-name and generic drug manufacturers about Synapse Labs, a research company in India, that falsified data in key studies used to gain approval of their medications. According to the agency, data from the company may have been used in hundreds of drugs that are still available for sale. European regulators first flagged Synapse to the FDA last year, leading the agency to say that companies that used Synapse for key studies would have a year to submit new data on the medications. "I think it raises a lot of questions about the implications for the drugs on the market," said Massoud Motamed, who was an FDA inspector until January 2023. (Edney, Bloomberg, 7/9)
  • Maryland: Earlier this month, Mike Bloomberg gifted $1 billion to Johns Hopkins University. The gift will make the medical school free for most students and increase financial aid for students enrolled in nursing, public health, and other graduate programs. Starting in the fall, Johns Hopkins will offer medical students free tuition for a year if their families earn less than $300,000 a year. Students whose families earn $175,000 or less a year will also have their living expenses and fees covered. "As the U.S. struggles to recover from a disturbing decline in life expectancy, our country faces a serious shortage of doctors, nurses, and public health professionals — and yet, the high cost of medical, nursing, and graduate school too often bars students from enrolling," said Bloomberg, who graduated from Johns Hopkins in 1964 and founded the Bloomberg business and financial data news company. "By reducing the financial barriers to these essential fields, we can free more students to pursue careers they’re passionate about — and enable them to serve more of the families and communities who need them the most." (Svrluga, Washington Post, 7/8)

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