The Food and Drug Administration (FDA) protects public health by approving new medicines for patients, ensuring unsafe treatments are not used and monitoring the evolution of scientific insights about the benefits and risks of medicines.
Part of this mission hinges on the robust flow of the latest scientific information – information that should inform patient care. However, the FDA’s current interpretation of laws and regulations governing medical communications is placing that free flow of information in jeopardy as biopharmaceutical companies are prohibited from sharing with health care professionals certain accurate, data-driven information about FDA-approved uses and medically accepted alternative uses of FDA-approved drugs.
In a recent article in the Food and Drug Law Journal, Jeff Francer, Natalie Turner and I address the key issues currently limiting communications with health care professionals. We also propose a modified framework for the FDA to consider with regards to information shared by biopharmaceutical companies.
The ultimate goal of this framework is to enhance patient care. More sharing of scientific information, including access to additional information about medicines that is developed from big data analyses after they have entered the market, will permit insurers, formulary groups and other health care professionals to compare alternatives and select the optimal therapies for improved patient outcomes and greater efficiency.
As a result of providing health care professionals with access to more robust sets of scientific information, patients will benefit from improved treatment options; physicians will be able to identify the particular risks and/or benefits associated with alternative therapies and select the most appropriate therapeutic option for individual patients based on their specific circumstanes and needs.
To be clear, a central feature of this modified framework is that it should apply only to discussions between biopharmaceutical companies and medically sophisticated audiences, such as health care professionals, scientists, and formulary committees—not communications directly with patients or other health care consumers.
We assess that such a framework should adhere to five key principles:
- All Communications about Medicines Should Be Truthful and Non-Misleading – To benefit patient care, all communications about medicines should be truthful and non-misleading; it should also be consistent with the First Amendment. Therefore, the FDA should not enforce a standard in which it censors truthful and non-misleading information shared by manufacturers.
- Balance Patient Benefit and Potential Risk to Determine Appropriate Limitations on Health Care Communications by Biopharmaceutical Companies – Health care professionals – including formulary committees – deserve access to accurate and robust information about the benefits and risks of medicines they prescribe for patient treatment. The standard for access to such information should be the same for both the FDA-approved uses for medicines, as well as alternative uses that are routinely prescribed.
- Permit Manufacturers to Use Robust Disclosures/Disclaimers to Disclose Limitations of Data Rather Than Prohibit Certain Health Care Communications – There must be precautions in place to ensure that medical communications remain data-driven and transparent about risks and/or limitations of scientific understanding. Adequate disclosures are a key principle to a successful framework.
- Provide Incentives for Sponsors to Continue to Seek Supplemental Indications for Approved Medicines – The FDA could streamline the process to approve new uses for already approved medicines by accepting data generated by real world evidence.
- Allow Companies to Provide Adequate Directions for Use for Both Approved and Medically Accepted Alternative Uses of FDA-Approved Medicines – Companies are the most knowledgeable sources about the medicines they produce, and therefore must be able to provide adequate directions for both approved uses and medically accepted alternative uses of FDA-approved medicines.
A regulatory framework that enables manufacturers to share accurate, data-driven information about complex, modern medicines will enhance patient outcomes. This framework, in particular, ensures that health care professionals can access the most comprehensive and timely information and data about certain treatments from the companies that know more about their medicines than anyone else. This access will enable health care professionals to make decisions for patient treatment based on information that is more up-to-date and comprehensive than what is available today.
We look forward to an ongoing dialogue with all health care stakeholders about the importance of providing all the latest accurate information so our health care system is efficient and effective for patients.
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