The American Society for Pharmacy Law (ASPL) is an organization of attorneys, pharmacists, pharmacist-attorneys and students of pharmacy or law who are interested in the law as it applies to pharmacy, pharmacists, wholesalers, manufacturers, state and federal government and other interested parties.

ASPL is a nonprofit organization with the purposes of

  • Furthering knowledge in the law related to pharmacists, pharmacies, the provision of pharmaceutical care, the manufacturing and distribution of drugs, and other food, drug, and medical device policy issues;
  • Communicating accurate legal educational information; and
  • Providing educational opportunities for pharmacists, attorneys, and others who are interested in pharmacy law

ASPL has become the premier source to engage with the entire spectrum of professionals at the intersection of pharmacy and legal matters. With my formal training, I approach our meetings with the assumption that I have grasped all of the components that contribute to the pharmacy profession. However, engaging with ASPL has placed context around the various, often overlooked, downstream and upstream factors that impact the law as it applies to pharmacy.
Monet Stanford, PharmD

Latest News

December 3,  2019

FRAUD, WASTE AND ABUSE
US Attorney for D. Mass. settles FCA allegations with patient assistance programs

On November 20, the US Attorney’s Office for the District of Massachusetts announced a settlement with a charity patient assistance program (PAP), The Assistance Fund (TAF), arising from alleged violations of the False Claims Act. TAF agreed to pay $4 million based on its ability to pay, and is the third such TAP to settle in what authors from Sidley Austin LLP noted is an “ongoing, industry-wide investigation.” The government’s position is that TAF, “in operating its patient assistance fund for multiple sclerosis ... conspired with three drug manufacturers and that TAF’s fund functioned as a ‘conduit’ for the manufacturers’ donations to patients taking their drugs.” Thus, “this resulted in Medicare patients not considering the high costs that the manufacturers charged for their MS drugs, undermining Congress’ purpose in introducing copayments to serve as a check on health care costs.”

The authors of the report noted that TAF operated under an OIG Advisory Opinion (No. 10-07), which provided a safe harbor from the Anti-Kickback statute, if TAF adhered to the provisions of the AO. In the settlement documents, the government alleged that TAF deviated from the AO’s provisions in that it gave preferential treatment to patients receiving drugs from Teva, Biogen, or Novartis, rather than providing its grants regardless of which drug the patient had been prescribed. The authors noted that during the investigation, another PAP’s AO had been rescinded. [Jones JLM, Fernandez W. Third foundation settles in industry-wide charity patient assistant program investigations. Original Source blog, Sidley Austin LLP, 2019 Nov 26; http://bit.ly/383a2bW]