Par Pharma Case Asserts That First Amendment Protects Truthful Off-label Speech

Oct. 18, 2011 – A case filed by Par Pharmaceutical, Inc. against the FDA seeks to preserve Par”s First Amendment right to provide truthful information to physicians and other healthcare providers about the off-label use of Par”s prescription drug, Megace® ES, which is approved for the treatment of anorexia, cachexia, or an unexplained significant weight loss in patients diagnosed with acquired immunodeficiency syndrome (AIDS).

In addition to prescribing Megace ES on-label to treat their AIDS patients, physicians frequently prescribe the drug off-label to treat wasting in non-AIDS, cancer, and geriatric patients. FDA regulations call for Par to refrain from speaking about the approved use of Megace ES to physicians who may prescribe the drug for unapproved uses.

According to a statement issued by Par, it hopes to “elicit tailored and constitutionally permissible regulatory guidance to ensure that physicians may be kept abreast of valuable, off-label information about prescription drugs to aid in their provision of quality and informed patient care.”

Coalition for Healthcare Communication Executive Director John Kamp is quoted in an article on the filing in Policy and Medicine, saying, “Par”s challenge goes directly to the heart of FDA”s jurisdiction to censor truthful speech by drug sponsors. After the Supreme Court decision in IMS, someone was bound to bring it. Now, the whole industry will be watching.”

To read the full Policy

and Medicine article, go to:

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