The Ninth Circuit ruled that a pharmaceutical manufacturer cannot sue a 503B compounding facility for compounding versions of its commercially available product in Nexus Pharmaceuticals, Inc v. Central Admixture Pharmacy Services (CAPS), Nexus... Read More
Pharmacy Benefit Managers (“PBMs”) regularly review network pharmacies to ensure that they are meeting terms and conditions identified in their Provider Agreements and Pharmacy Manuals. One mechanism for this review includes audits and... Read More
As previously reported, Frier Levitt filed suit against the New York Department of Health and the New York State Department of Education on behalf of an independent New York oncology practice in an effort to void the State’s new and legally... Read More
In the past week alone, Frier Levitt has seen a sudden increase in actions by pharmaceutical manufacturers against pharmacies related to the use of certain patient savings programs, such as copay coupon programs. These programs are designed to... Read More
In May 2022, Johnson & Johnson (“JNJ”) filed a lawsuit against Save On SP, LLC (“SaveOnSP”), essentially alleging that SaveOnSP illegally pilfered co-payment coupon and manufacturer assistance programs offered by JNJ to help patients... Read More
In preparation for the final complex interoperable electronic tracking phase for the Drug Supply Chain Security Act (“DSCSA”) provisions, FDA released two Guidances the week of July 5, 2022. DSCSA Standards for Interoperable Exchange... Read More
In a recent trend, compounding pharmacies have been receiving notices of audit from the Office of Inspector General (“OIG”) of the U.S. Department of Health and Human Services (“HHS”). In the notice, OIG requests that the pharmacies submit... Read More
Last week, the Federal Trade Commission (“FTC”) fired a warning shot across the bow of PBMs, but Manufacturers and Plan Sponsors must also take note. On June 16, 2022, the FTC announced that it will “ramp up enforcement against any illegal... Read More
The New York Department of Health (NYDOH) has promulgated enrollment requirements for pharmacies seeking to participate in the Medicaid program which are unrelated to many of the actual operations of pharmacies within the state of New York.... Read More
On May 17, 2022, the United States District Court for the District of Columbia issued an opinion granting Summary Judgment to Pharmaceutical Research and Manufacturers of America (“PhRMA”), and setting aside the December 2020 Medicaid Best Price... Read More
