Marketing drugs for non-approved uses is standard operating procedure for Big Pharma, and the law suits, fines and multi-million-dollar settlements are apparently just a ‘cost of doing business’.
An Associated Press article analyzing the recent report from the Government Accountability Office on off-label drug marketing by pharmaceutical companies points out the serious lack of resources at the FDA to police such activity.
“When a state trooper pulls over a speeding motorist, the officer usually writes out a ticket on the spot,” the AP story says. “When federal regulators catch a drug company peddling prescription medications for an unapproved use, it takes them an average of seven months to issue a warning . . . [and] typically takes four more months for the company to fix the problem. During that time, a lot of prescriptions can be written.”
The FDA is “ill-equipped to catch even blatant marketing abuses by drug companies,” the AP story continues. No staff are assigned to monitor drug marketing for unapproved uses. Instead, less than 3-dozen people — 44 employees — who oversee print and television advertising, are expected to do the job. Last year alone, they had to analyze 68,000 ads — not much time for the complex investigation it requires to monitor all drug marketing to the medical profession. Drug marketing is not all advertising, but includes scientific papers, events, conventions, personal visits to doctors’ offices, and other avenues of communication. The GAO report found that the agency lacks even a system for tracking all the material it receives.
Sen. Charles Grassley, R-Iowa, who spearheaded the GAO audit, says federal programs like Medicare and Medicaid pay billions for questionable prescriptions, all the while lining Big Pharma’s pockets.
The FDA “isn’t keeping track of how drugs are marketed for off-label use, even though marketing for off-label use is illegal and it’s the FDA’s job to enforce that law,” Grassley said. “As a result, drug makers aren’t being held accountable for promoting unapproved use of medicine and patient safety is diminished.”
Of course, doctors are legally allowed to use their own judgment prescribing drugs. And new guidance proposed by the FDA would allow drug companies to tell doctors about scientific articles that suggest unapproved uses for medications.
But it is still illegal for drug companies to promote uses not validated by the FDA based on clinical trials. And a 2006 study suggests that more than 20 percent of prescriptions are off-label — little more than an uncontrolled experiment using patients as guinea pigs.
While some patients benefit, others do not, and some are even injured or killed by side effects from prescriptions that should never have been written.
Bristol-Myers Squibb’s $515 million settlement last year for “alleged” infractions, including fraudulently promoting Abilify for dementia-related psychosis and children, is being distributed among a couple of dozen states as well as federal agencies. And that’s just the tip of the off-label marketing iceberg.
The same kinds of suits involving other Big Pharma players have been in the news for years. Unless the FDA gets its act together and staffs up a dedicated team, the fraud, the injuries, and the deaths, will just continue.