Culture is defined as patterns of human activity communicated through rituals and symbols. In healthcare, the pharmaceutical
industry fosters cultural change in by developing treatments that alter the practice of medicine. But now, the culture of
the industry itself is facing profound change, as society—and FDA—focuses increasingly on drug safety in the wake of the withdrawal
of Vioxx (rofecoxib) and questions surrounding the safety of Avandia (rosiglitazone).
A Guide to the New Safety Culture
We can already see signs of this cultural shift. Take Arcoxia (etoricoxib), the new Merck product designed to enter the COX-2
market. There was no evidence that Arcoxia was very different from other COX-2 drugs, and the FDA advisory committee voted
Arcoxia down 20-1, and FDA rejected the drug. In years past, Merck might have won with its argument that patients needed another
option. In the new culture of safety, however, concerns over risks carried the day. (Disclosure: As a former member of the
Drug Safety Advisory Committee, I voted against the approval of Arcoxia and for the continued marketing of Vioxx.)
Reflecting this new culture, FDA is making structural changes to the way it reviews drug safety. Some changes are based on
recommendations from an Institute of Medicine (IOM) report entitled The Future of Drug Safety. (See "IOM Gives FDA Five,".) In line with IOM's recommendations, FDA created the office of Drug Safety Policy and Communications
and increased its postmarketing staff by 25 percent to 132 positions. The agency has also created an internal Drug Safety
Oversight Board, issued drug safety alerts and public health advisories at a more rapid pace and earlier in the drug safety
investigation process, and is beginning the public hearing process on a variety of drug safety assessment and communication
Still, it is difficult to know what specific new requirements will emerge. Through the Office of Management and Budget, the
administration has voiced its concerns about the FDA Revitalization Act (S-1092), which proposes sweeping changes in drug
safety tied to user fees, and which the Senate passed by a vote of 93-1. House bill HR-1561, similar to the Senate bill, was
recently introduced, adding more fuel to the drive for change in the way FDA regulates drug safety.
Currently, we don't know what a new law will specify. But we are starting to better understand what FDA's new philosophy of
drug safety means and how it will affect the regulation of drug development and marketing.
IOM Gives FDA Five
From Launch to Life cycle: Sales and Safety
We used to see drug safety as something that was dealt with during drug development. Once a drug launched, marketing was supposed
to run the show. But in the new Culture of Drug Safety, the side effects of drugs remain under the microscope not only after
launch but throughout the product's life cycle.
That's a big change for pharma. For the past few decades, companies have maintained an inordinate focus on drug launch. The
time between the FDA approval letter and the initiation of a drug's marketing and sales effort has been like the birth of
a favored child. With today's new focus on safety, the child may still be favored, but it is much clearer that, as with a
newborn, we don't know much about it. We think we know its potential to treat disease, but we no longer have sufficient experience
to fully characterize its safety profile.