To hear individuals who put in time at the Food and Drug Administration in the late 1960s and early ’70s tell it, today’s healthcare execs and observers wouldn’t recognize the “tiny” and “sleepy” unit it once was. But for those who wonder how the FDA evolved into the almost imposingly influential force it is today, the answers lie in a transformational decadelong period in which the organization started to throw its weight around. In doing so, it laid the foundation for the greater transparency in the drug-approval process and patient communications now taken for granted.
Take it from Wayne Pines. As chief of consumer education there during that era, he recalls that among the FDA’s highest-priority projects were the dissemination of information about the possible effects of caffeine in pregnant women and attempts to ban red food coloring and an artificial sweetener called saccharin.
“The ’70s were a transformational era for the FDA,” Pines says. “It propelled the organization from a tiny agency into the front-page agency that it is today.”
Pines recalls that the agency’s ambitions were fueled in part by external criticism. The barbs that stung most sharply were ones suggesting a certain indifference on the FDA’s part, that there was a “drug lag” — that it was delaying the approval of drugs that were already available overseas.
The problem was one of optics, Pines notes. “The drug-approval process was nothing like it is today. It was very secretive back then,” he says.
So the FDA created public advisory committees, the importance of which remains clear. Not only do they allow for more transparency vis-à-vis the public about drug approvals (and denials), but they also allow different voices to be heard.
At the same time, the FDA has not wavered in its commitment to involve patients in the drug-approval process. In the FDA’s proposed enhancements to the fifth reauthorization of the Prescription Drug User Fee Act, the agency outlined that it wants to further incorporate the patient perspective in at least 20 disease areas by the end of its 2016 fiscal year.
During the late 1970s and early ’80s, the agency laid the foundation for such efforts. “Back in the ’70s, drugs were sold by sales reps or via advertising in medical journals,” Pines recalls. When the FDA embraced its responsibility to bring new drugs to market, it opened marketing doors: “From a marketing standpoint, it was the beginning of promoting drugs.”
See also: Wayne Pines on How The FDA Advanced DTC
That patient-marketing push began with brochures. The first, which debuted in the early 1970s, conveyed information about the then-novel topic of oral contraceptives. In many ways, this represented the first real outreach to patients about new treatments.
With these brochures came the first package inserts. In 1968, the FDA mandated that an inhaled medicine, isoprenaline, contain a warning note explaining risks about excessive use. In 1970, the FDA required makers of oral contraceptives to include information about specific risks and benefits.
“Now it’s commonly accepted that patients are entitled to information about the drugs they take,” Pines says. “But in the 1960s, nobody knew what drugs were being prescribed. In the past 50 years, we’ve gone from zero information for patients — and zero involvement by them — to DTC ads.”
Fast-forward 50 years and the debate over how to communicate with patients rages on. In 2009, on a single day in April, the FDA issued 14 warning letters to drugmakers over the “one-click-away” rule, which, marketers then found out, really wasn’t a rule at all. It was more an unwritten admission that if risk information was only one click away from a drug’s online promotion, it fell within regulatory parameters.
The situation remains unsettled. “There are still questions about the one-click-away rule,” John Kamp, executive director of the Coalition for Healthcare Communication, says.
“The FDA, at least in some people’s view, refuses to accept the reality of new media,” Kamp continues. “You can’t treat the internet like it’s a print page in a journal. We all know how to use links. The FDA should recognize that.”
So where does the FDA go from here? Peter Pitts, who was the FDA’s associate commissioner for external relations from 2002 to 2004, believes the agency needs to do a “better job of leading than following.” If it doesn’t, the FDA risks adding further ambiguity to a process that many marketers already believe has too many gray areas. “Social media, off-label communications — the FDA has been ambiguous in its pronouncements,” Pitts says.
Off-label communications should be a major issue in coming years, especially in the wake of legal setbacks. The U.S. District Court for the Southern District of New York ruled in favor of Amarin in a dispute over whether the First Amendment protects manufacturers from FDA accusations of off-label marketing. Last December, the FDA settled a similar case with Pacira Pharmaceuticals concerning pain treatment Exparel.
THE WAY FORWARD
Pines says that although the FDA has a record of making “sound scientific decisions with regard to products and risk based on the available data,” it has not been timely in its issuance of new guidances.
“The agency needs to update its policies with regard to the regulation of marketing communications,” he explains. “We’ve had a number of recent court cases that have raised fundamental questions about the regulatory standards that currently exist. The agency has been trying to deal with it, but needs to do so in a more timely fashion.
“It’s ironic that patients have access to so much misinformation on the internet,” Pines continues, “yet the companies that know the most are the most heavily regulated about what they can communicate.”