Transparency and Trust in Health Communications
Bob Perkins, Vice President, Public Policy, AstraZeneca
On May 19th, the U.S. Food and Drug Administration (FDA) Transparency Task Force suggested broad changes that would increase public access to information about the regulatory process.
As Tiffany O’Callahan explains in a TIME Magazine Wellness blog post, the draft proposals include increased disclosure of information about drugs that have been put on hold, terminated or withdrawn and the rationale behind these decisions; more open access to decision letters about products or drugs that have not met agency approval; access to improved information about timing and results of facility inspections; and efforts to improve clarity about the specific products affected by large-scale food recalls.
I think it’s important to recognize that the FDA is not alone in its increasing focus on transparency. Transparency is vital in the healthcare industry. Especially in today’s digital era, companies engaging in health need to be more transparent about their practices and positions. To that point, here are a few of my thoughts on this issue:
- Talking about transparency does not equal transparency.
- This would seem obvious, but the reality is pharmaceutical companies need to “show” and not “tell.” AstraZeneca’s position on corporate transparency can be found on our company’s Web site. You’ll find links to information on AstraZeneca’s clinical trials, medical education grants, political contributions and other information.
- Patients want more information, and the FDA wants to provide it.
- Whether it’s increasing the public understanding of what the FDA does, enhancing knowledge about how blockbuster, life-saving medicines are made or simply providing more information on health conditions, patients and government are aligned. More information is wanted and needed.
- Social media practices can take a note from this briefing and principle of transparent communication. Online communication is still a new frontier for pharmaceutical companies, with no formal FDA guidelines available yet.
- AstraZeneca believes health care companies have an obligation to responsibly engage in social media to help patients, caregivers and prescribers make informed decisions about our medicines. We published guidance submitted to the FDA for pharmaceutical companies to engage in online conversations on branded medicines. At the core of our proposal are five important principles for online dialogue.
- Engaging in open, honest dialogues with the public is in the best interest of patient health, and it is our responsibility to be open about how we both conduct business and engage online.
You can see what others are saying about the FDA’s Transparency briefing at the FDA Transparency Blog. If you’d like to read the complete draft proposals, you can find them online here. Public comments will be accepted through July 20th.