Legal Notes

A Last Minute Approval Gives FDA User Fee Reauthorization

Courtesy of Apotex

At last! After nearly a year of committee hearings and political maneuvering, Congress finally has approved legislation to reauthorize FDA’s user fee programs for brand and generic drugs, biosimilars, and medical devices. The current programs expire with the close of fiscal year 2022 on September 30. Reauthorization will enable FDA to continue collecting application and facility user fees from industry for fiscal years 2023 through 2027, a 5-year period that begins October 1. Read more.

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Judge Rejects Antitrust Challenge to UnitedHealth Acquisition

A federal judge ruled on September 19, 2022, against a Justice Department antitrust challenge to UnitedHealth‘s $13 billion acquisition of health-technology firm Change Healthcare, rejecting government claims that the deal would unlawfully suppress competition and limit innovation in health-insurance markets.

U.S. District Judge Carl Nichols ruled for the companies in an opinion that he kept under seal for now because he said it “may contain competitively sensitive information.” The judge said he would release a redacted public version of the ruling in the coming days. In a one-page public order, he denied the Justice Department’s request to block the companies from completing the deal. Read more

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Inflation Reduction Act Becomes Law: How Will It Affect Health Care?

Under the new law, the U.S. government is now able to negotiate prices on the costliest prescription drugs, cap costs at $2,000 per year for people on Medicare, limit the monthly cost of insulin to $35 for seniors, and extend subsidies for people buying their own health coverage through the Affordable Care Act, also known as Obamacare. The law also provides free vaccines for seniors. Read more.

What to expect in the 2022 – 2023 flu season

Flu season is fast approaching. And it’s more important than ever for patients, particularly those who are at risk, to be vaccinated against influenza. Adults 65 and older, along with those with severe health problems, people of color and those of lower socio-economic status are at higher risk of developing severe complications from the illness. Getting vaccinated can help protect these vulnerable populations. Learn more about the selected strains, changes to vaccine recommendations and what to expect next.

Under Attack: Protecting your patients’ personal information

Did you know that more than one-third of health care organizations in the United States were hit by ransomware attacks in 2020? Approximately 65% of these attacks were successful, and approximately one-third of the organizations that had data stolen paid up. However, only 69% of organizations that paid ransom actually got their data back. Here are some tips to help you protect your patients’ information. Read more

PBM ruling for North Dakota stands

With PCMA’s failure to file its appeal by the July 11, 2022 deadline, North Dakota can regulate PBMs as it sees fit. PCMA has exhausted its legal options. So, the ruling in PCMA vs. Wehbi is now the law of the land for the states in the 8th Circuit (Arkansas, Iowa, Minnesota, Missouri, Nebraska, North Dakota and South Dakota). Read more

Florida Governor DeSantis signs PBM executive order

As expected, Florida Governor Ron DeSantis signed the PBM transparency order.  The order is aimed at lowering the price of prescription drugs. AAP Member Ben Levine was at the governor’s side during the signing. Levine calls this order a victory for all Floridians. “This transparency will really help drive down drug prices, and also improve access for patients in our community so that they can go to the pharmacy they choose.” Read more about the executive order.

AAP Member Ben Levine

FDA allows pharmacists to prescribe Paxlovid for COVID-19 treatment

01 March 2022, Berlin: The drug Paxlovid against Covid-19 from the manufacturer Pfizer is lying on a table. Photo: Fabian Sommer/dpa (Photo by Fabian Sommer/picture alliance via Getty Images)

It’s a win for pharmacies, which had been pushing for the FDA to allow them to prescribe the medication, saying that it would ultimately expand access to the antivirals. 

Paxlovid is authorized for the treatment of “mild-to-moderate” COVID-19 in adults and pediatric patients that have tested positive and are considered to be at high risk of developing severe disease.

Read more about the authorization.

Cardinal Health issues new alert on fraudulent activity

Cardinal Health issued a new alert regarding recently reported fraudulent activity. There are reports of individuals falsely claiming to be representatives from pharmaceutical wholesalers and courier service employees. This is an industry-wide issue, as criminals attempt to place orders and intercept delivery of the product. Be on the lookout, and read the full alert here.