Pharma Petitions FDA for Binding Off-Label Rules


Eliminating illegal off-label promotion while engaging in legal scientific discourse around unapproved uses to ensure patient safety is a difficult line to walk for medical device and pharmaceutical companies. Today, the current broadly-written laws are open to expensive and retrospective interpretation delivered by the FDA, DOJ  and HHS via detailed warning letters, untitled letters, CIAs and DPAs. This is unproductive.

Seven pharmaceutical companies filed a Citizen Petition to FDA for Off-Label Guidance on July 5th in order to force FDA to issue proactive and binding rules around conveyance of off-label medical information. The petition asks that FDA provide clear guidance on:

  1. How companies should respond to unsolicited requests from physicians, and establishing clear boundaries for that allow for information exchange.
  2. The rules supporting the interest of scientific exchange for companies who develop and produce drugs and medical devices.
  3. Boundaries for allowable communication and interactions with involved health care entities, e.g. formulary committees, payors, and others.
  4. The extent of allowable dissemination of third-party clinical guidelines including other medical professionals, academic institutions and even other government agencies, which can include off-label recommendations.

The request that concludes the petition respectfully urges the FDA to establish “comprehensive, clear and binding regulations to guide the industry.” If the FDA does not accept the challenge, the question will become, why not? Is it about doing the right thing for American healthcare consumers or is it about the tremendous monies in fines that look good in the government’s coffers?

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3 responses to “Pharma Petitions FDA for Binding Off-Label Rules

  1. Pingback: Attacks on FDA’s Aggressive Stance: Off vs. On-Label | Good Promotional Practices

  2. Pingback: Unsolicited Off-Label Discussion Permissible in Industry-Sponsored Speaker Programs | Good Promotional Practices

  3. Pingback: Why waste time with “draft” guidelines for the FDA ? | World of DTC

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