New Study Calls for Informed Prescribing to Further Patient Access

by Amanda Conschafter, blog editor

A new study from the Food and Drug Law Journal argues that fewer restrictions on communication between pharmaceutical companies and physicians would foster better-informed prescribing decisions. The study addresses restrictions on communication about off-label drug uses specifically. Companies’ inability to share truthful, data-driven information on off-label uses may violate First Amendment free speech rights, the authors contend. Worse, it may deny physicians the knowledge they need to apply medications’ full value to patients.

The FDA’s complex regulatory structure means to protect patients from unsafe or ineffective medications. But, the study explains, regulation cannot keep pace with pharmaceutical innovation. Medications may prove effective for conditions before or without being FDA approved for those indications. Off-label use has thus become a health care norm; the FDA has acknowledged the practice’s value, and many insurance providers cover off-label uses.

Without full knowledge of drugs’ off-label applications, however, physicians may not be equipped to prescribe medications for these uses.

[READ: IfPA’s “Informed Prescribing to Further Patient Access”]

The restrictions are somewhat ironic. Though physicians get information about medications from a variety of sources, the pharmaceutical company that created the medication arguably has the most – and most timely and accurate – data. However, the FDA prohibits or severely restricts companies from sharing information on uses not expressly approved in the drug’s indications.  If companies fail to comply, they can face criminal charges for “misbranding” – and pay hefty fines.

Patient and provider groups have spoken out against FDA’s information-sharing restrictions. To meet their demand – and to promote more complete information for prescribing physicians – the FDA should consider several basic principles, the study explains. These include:

  1. Fair application of communication standards. The FDA should apply its requirement for truthful and non-misleading data fairly to all sources – not discriminate against specific sources, such as pharmaceutical companies.
  2. A balanced approach. Communication regulations should balance patient risk considerations with the potential for patient benefit.
  3. Use of disclosures. Instead of restricting communications, the FDA could allow companies to provide disclosures on the limitations of data provided to physicians.
  4. Incentives for additional indications. Streamlining the regulatory approval process might incentivize companies to pursue approval for uses beyond a medication’s original indications.
  5. Modified regulatory framework.   The FDA could broaden regulations so companies can share truthful information about both approved and data-supported off-label uses for a medication.

If applied, these principles could provide patients with more options for medical therapies – and physicians with a fuller understanding of what FDA-approved medications can offer the patients they serve.

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