Because a drug is designated an “Orphan” if it is intended to treat a “rare condition,” the condition itself always has been integral to Orphan Drug Exclusivity. Indeed, the condition for which the product is intended to treat dictates the prevalence calculation by which FDA …
In what is sure to be a process that will take potentially years to complete, FDA completed its final review of twelve bulk substances to be used in compounding by Section 503B Outsourcing Facilities. FDA announced its decision in both a Federal Register Notice, and …
Well, OPDP is kicking off 2022 in a big way – taking on an Eli Lilly Instagram post with video for Trulicity. This is the second time in a little over a month that Eli Lilly has found itself caught in OPDP’s cross-hairs. On the …
FDA has released its Proposed Rule of National Standards for Third-Party Logistics Providers (“3PLs”) and Prescription Drug Wholesale Distributors (“WDDs”). The Drug Supply Chain Security Act (“DSCSA”), enacted back in November 2013, directed FDA to create national licensure standards for wholesale distributors and 3PLs within …
I don’t mean to be so pessimistic, but 18 months after opening a docket requesting comments on potential “modernizations” for the Orange Book and one year after the passage of the Orange Book Transparency Act, FDA issued its Report on Orange Book reform essentially concluding …
The Justice Department’s Prescription Interdiction and Litigation (PIL) task force strikes again? Not quite yet, but maybe soon, as explained below. The United States filed a Complaint against Texas entities Zarzamora Healthcare LLC, Rite-Away Pharmacy and Medical Supply #2– and its Pharmacist-in-Charge (PIC), and part owner. …
We are working to keep up with OPDP’s posts over the past few weeks and a blog on its most recent letter to Lilly is forthcoming! With apologies to Rob Base and DJ EZ Rock, it took more than “two” to get this Emgality DTC TV …
Since the August 2021 decision in GSK v. Teva, the generic industry has been waiting with bated breath to see whether the section viii carve-out (and thus skinny-labeled generic drugs) will survive. With the District Court of Delaware’s January 4 decision in a similar case …
Happy New Year! On January 1, 2022, the recently revised version of the PhRMA Code on Interactions with Health Care Professionals went into effect. We summarized the major revisions to the Code in a blog post when it was released in August 2021. Many of the …
Since California passed AB 824: Preserving Access to Affordable Drugs in September 2019, the Association for Accessible Medicines (“AAM”) has been trying to invalidate the law, which imposes a presumption of anticompetitive effect on any Paragraph IV patent settlement in which the generic sponsor receives …
There’s a lot of things packed (and that need to be unpacked to understand) into the latest version (as amended) of H.R. 5376, the 2100-plus page bill better known as the “Build Back Better Act.” The bill has gone through the House Committee on Rules …
While most of the Congressional focus on drug pricing has centered on the reconciliation bill currently being hammered out in the House and Senate, the Infrastructure Investment and Jobs Act (the “Act”), which was signed by President Biden yesterday, contains two provisions relating to drug …
As surveyed in detail by our colleagues in an earlier blog post, FDA’s PDUFA VII goals letter, for fiscal years 2023-2027, is full of announcements and new agency initiatives. One of those announcements is a commitment to create a new process for reviewing sponsor-initiated requests …
Last week, we blogged about a growing list of drug manufacturers that have refused to follow a 2010 guidance issued by the Health Resources and Services Administration (“HRSA”), which permits 340B covered entities to contract with multiple pharmacies to dispense drugs to covered entity patients. …
In the appellate courts lately, it’s been FDA “Against the Music.” In yet another decision based on statutory interpretation, an appellate court has decided that FDA’s interpretation of the Federal Food, Drug, and Cosmetic Act (FDCA) is contrary to the plain text of the statute. …
