FDA plans risk communication review

Share this article:
A significant effort by FDA is now in "the planning stage," designed to determine how patients, physicians and other healthcare providers obtain information about emerging risks associated with drugs and medical devices, according to Nancy Ostrove, Office of the Commissioner senior advisor for risk communication.

Speaking at a workshop on risk communication in Bethesda, MD, Ostrove said the research study is expected to yield "quantitative as well as qualitative data" on how patients and providers get risk information, as well as their perceptions concerning various formats and means of distribution of public health advisories. The study will include a national survey of providers, and focus groups comprised of patients and consumers.

The need for research to help guide FDA's future risk communication efforts was revealed by the results of a public hearing on the subject, held last December, Ostrove said. Testimony at the hearing criticized the agency's Web site as "too complex" and "difficult to navigate."

More recently, Ostrove said a study of indicated physicians and pharmacists believe that learning about product risks through the popular media (press, television), while rapid, is often simplified, one-sided and unreliable. Information from professional sources (meetings, newsletters, journals) was generally viewed as credible and objective.

While information received from FDA was generally viewed as credible it was often "slower than from other sources"—in some cases even slower than information acquired from professional journals.

Share this article:

Email Newsletters

More in News

Meaningful use not linked to quality: study

Meaningful use not linked to quality: study

A recent study of physicians found no correlation between following EHR meaningful use requirements and providing consistently higher quality of care.

Lilly Q1 sales dip

Lilly Q1 sales dip

US sales fell 34% during the quarter, largely due to lower demand and lower prices for off-patent Cymbalta and Evista.

Gilead reaps huge HCV sales, payer fury

Gilead reaps huge HCV sales, payer fury

Sovaldi's debut has been marked by plenty of criticism from payers and lawmakers, but the hep. C drug's launch, now confirmed to be the fastest of all time, has also ...