Justice Department Wants Whistleblower Case Against Gilead To Be Tossed By Supreme Court
The long-running suit involves allegations that Gilead misled regulators about contaminated ingredients used in various HIV medicines and falsified data to win marketing approval for the drugs. In its brief, the Justice Department argued the case may burden the FDA, but otherwise did not explain how it would not be in the public's interest for the Supreme Court were to take up the case. Other pharmaceutical news looks at gift giving and gene therapy.
Justice Departments Tells Supreme Court It Wants To Scuttle Case Against Gilead
In a surprising development, the U.S. Department of Justice filed a brief telling the U.S. Supreme Court that it wants to end a closely watched whistleblower lawsuit filed against Gilead Sciences because it is “not in the public interest.” Moreover, the Justice Department further indicated it would seek to dismiss the case if the Supreme Court were to send it back for further review by a federal circuit court, even though the agency appeared to support the legal theory underpinning the case. (Silverman, 12/3)
Philly City Council Committee Eases Ordinance To Restrict Sales Reps
After lobbying by the pharmaceutical industry, a Philadelphia City Council committee late last week agreed to amend a controversial ordinance that would ban drug makers from giving gifts to doctors and also require all sales reps to become licensed in hopes of blunting the opioid crisis. The key concession by the lawmakers was to offer an exemption for conventions, while yet another exemption would delay enforcement for 180 days after the ordinance becomes law. As it so happens, the BIO trade group has such an event scheduled in Philadelphia in early June. (Silverman, 12/3)
Bluebird’s Gene Therapy Improved Outcomes For Patients In Clinical Trial
Bluebird Bio presented data Wednesday that for the first time links its gene therapy for sickle cell disease to improved clinical outcomes for patients. It’s part of a plan to speed up a regulatory filing for the one-time treatment called LentiGlobin. In many ways, Bluebird is following the successful sickle cell disease regulatory playbook written by Global Blood Therapeutics. Both companies are seeking to take advantage of flexibility at the Food and Drug Administration and a desire to see new sickle cell treatments reach the market. (Feuerstein, 12/3)