As I had noted last week, allegations concerning Amgen’s practices have the potential for huge consequences. Unsurprisingly, the New Jersey Attorney General’s office opened an investigation. From the press release [pdf]:
Attorney General Anne Milgram announced today that the State has issued a subpoena to the pharmaceutical company AmGen, Inc. concerning allegations that, in an effort to increase the sale of its injectable drug Enbrel, the company violated patient confidentiality laws and marketed the drug for uses for which it was not approved.
The principal focus of the State’s inquiry is whether AmGen, Inc. unlawfully engaged in “off-label” marketing — essentially promoting a drug for uses other than those for which it was FDA-approved – and whether the company violated medical privacy laws for the purpose of direct marketing.
Served on January 14, the state subpoena calls on AmGen to deliver the required materials to the Division of Consumer Affairs offices in Newark by February 4, 2008. The state’s investigation is being conducted by the Affirmative Litigation Unit within the Division of Law.
Amgen’s problems don’t stop there. Ed Silverman, writing for Pharmalot, notes that the Senate Finance Committee is also investigating Amgen as part of a broader investigation of pharmaceutical companies’ marketing practices and payments to doctors. Senator Chuck Grassley has sent an email to the attorney for the two former employees who have made the allegations, seeking information from them.
One of the obvious implications of the allegations, if proved, is that physicians may have been allowing sales representatives access to patient records, which could be a HIPAA privacy violation. Others had also pointed out that physicians might potentially be charged with authorizing “marketing of medication not designed to treat their patients” and presumably for their own financial gain.
Leave it to a lawyer to already think up with a strategy to defend a physician who might be accused of violating the HIPAA privacy rule. Jeffery Drummond, J.D., a partner at Jackson Walker, LLP, maintains a HIPAA-related blog. He writes:
It may be possible to couch the activity as a part of the physician’s healthcare operations (in the way of education, for example). But it could be illegal marketing.
I guess lawyers get paid big bucks to keep a straight face while they try to convince judges and juries that their clients’ behavior was not just an egregious disregard for patient privacy. I can picture it now:
Your Honor, my client is dedicated to keeping current and exploring all possibilities for his patients. That’s why he routinely — as part of his healthcare operations — allows others access to patient files — so maybe they’ll see something that he missed and that would benefit his patients. He really means well, Your Honor, and instead of facing these ridiculous charges, he should be nominated for Doctor of the Year!
If I ever find out that any of my doctors permit nonmedical or non-office personnel to look at my chart or records without my consent, they’re toast.
Update of Jan. 22: now the Florida Attorney General is also looking into Amgen’s marketing practices.