Regulatory/Legislative News

The New York attorney general, Letitia James, has filed a lawsuit against a Manhattan stem cell clinic and the physician running it for allegedly selling unproven treatments for lupus and other autoimmune conditions, among others.

As Norman “Ned” E. Sharpless, MD, prepares to become acting FDA commissioner in a few days, experts are divided in how he should address the explosion of e-cigarette use among minors and the devastating opioid epidemic whose tide has not turned.

The Australian Department of Health Therapeutic Goods Administration has issued a Therapeutic Goods Certificate to the Implantable Miniature Telescope, VisionCare announced in a press release.

Norman E. “Ned” Sharpless, MD, director of National Cancer Institute, will replace resigning FDA commissioner Scott Gottlieb, MD, according to a tweet from Gottlieb.

FDA Commissioner Scott Gottlieb, MD, announced he will step down from his position early next month, leaving a 2-year tenure as head of the agency.

As a former adviser to several federal entities, FDA Commissioner Scott Gottlieb, MD was familiar with public service before he assumed his current position in early 2017.

FDA Commissioner Scott Gottlieb, MD, announced his resignation effective 1 month from Tuesday, March 5, according to an HHS press release.

Representatives from AbbVie, AstraZeneca, Bristol-Myers Squibb, Janssen Pharmaceuticals, Merck, Pfizer and Sanofi voiced support for drug rebate reform, value-based program creation, and increasing transparency, biologics and generics awareness to lower U.S. drug prices at a recent Senate Finance Committee hearing.

With all of the attention currently placed on prescription drug prices, it’s difficult to believe that a major retail distributor of medications would do anything but toe the proverbial line when it comes to sales practices. However, last month, Walgreens was ordered to pay more than $270 million for improperly billing Medicare, Medicaid and other state- and federal-level programs over the course of 10 years.

In the Aug. 25 “The Dry Eye” follow-up to my “Follow the Money” series on how drugs are priced in the marketplace, I noted that HHS announced a possible removal of the safe harbor that allowed pharmaceutical companies to pay rebates to the pharmacy benefit managers that paid for their purchases by patients. It looks like it was serious. Recently the administration pledged to change how pharma rebates were directed in order to reduce the real cost of medicine for patients.