Dive Brief:
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Gilead Sciences, Biogen Inc. and Jazz Pharmaceuticals have been subpoenaed in a federal investigation into the relationship between pharmaceutical companies and nonprofits that help patients afford prescription drugs, Bloomberg News reported.
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The three join Valeant Pharmaceuticals, which disclosed in October it had been subpoenaed for documents involving its patient assistance program.
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The seven largest "copay charities" received $1.1 billion in 2014, which is more than double their 2010 receipts, Bloomberg reported.
Dive Insight:
You have to dig a little, but there are disclosures of the subpoenas in the most recent quarterly 10-Q disclosure reports the companies must file with the Securities and Exchange Commission.
Gilead's last 10-Q states that it received a subpoena in February from the U.S. attorney's office for the District of Massachusetts "requesting documents related to our support of 501(c)(3) organizations that provide financial assistance to patients, and for our HCV products, documents concerning our provision of financial assistance to patients." It also received a demand for documents from the Massachusetts attorney general's office in February "requesting that we produce documents related to our HCV products."
Biogen's 10-Q said it had been subpoenaed in March by the federal government "for documents relating to our relationship with non-profit organizations that provide assistance to patients taking drugs sold by Biogen," but it did not disclose what federal agency issued the subpoena. Jazz, in its 10-Q, said it had been subpoenaed earlier this month by the same U.S. attorney's office as Gilead. All three companies said they are cooperating or intend to cooperate with the investigating authorities.
Federal law prevents drug companies from giving direct co-pay assistance to Medicare patients, but those patients can turn to the nonprofits for assistance as long as the companies don't influence the operations of the nonprofits.
That last point is key and is likely the focus of the investigation. If a nonprofit was to back one company's drug over a competitor, it could violate Medicare provisions against kickbacks, Bloomberg noted. The news service published an article earlier this month investigation whether high drug prices have been propped up by the assistance the charities provide.
Here are the latest 10-Q filings for the three companies. Click on the title of the document to pull up a larger PDF version in a new browser window:
Biogen:
Gilead:
Jazz: