October 17th, 2011

Par Pharma: Free Speech Muffled By The FDA

By Ed Silverman

In yet another clash between the pharmaceutical industry and the FDA over discussing prescription drug usage with doctors, Par Pharmaceutical has filed a lawsuit contending that its ability to convey “truthful” information to physicians is protected by the First Amendment, yet is thwarted by agency regulations governing off-label promotion.

At issue, Par argues, is its ability to talk to physicians who may prescribe one of its drugs for unapproved uses. The drug in question is Megace ES, which was approved by the FDA in 2005 to treat anorexia, cachexia or unexplained weight loss in AIDS patients. Par notes that doctors prescribe Megace to treat wasting in other patients, such as the elderly or those with cancer.

The drugmaker “contends that the government’s effort to minimize off-label use by means of banning Par’s truthful speech is unjustified since off-label use is lawful, widespread, medically necessary and reimbursed by the federal government under the Medicare and Medicaid programs,” Par says in a statement. “Through its suit, Par hopes to elicit tailored and constitutionally permissible regulatory guidance to ensure that physicians may be kept abreast of valuable, on-label information about prescription drugs to aid in their provision of quality and informed patient care” (we will link to the lawsuit as soon as we obtain a copy).

Read more: http://bit.ly/pYCuE2


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