I was speaking to a source inside the FDA recently and he explained that since the FDA has committed to reviewing applications for approval of a new drug within 10 months, drug-makers have been submitting “shabbier” applications that contain less evidence about risks and benefits.
“For the drug-maker it’s a gamble. The company is betting that, because we want to make the 10-month deadline, we won’t send the application back,” said the source. And often, he acknowledged, the drug-maker is right. “If you find a problem or there is something missing and it doesn’t seem terribly material, there is a tendency to overlook it. Because if you don’t it will just delay the whole process.”
In the past, he adds, a company submitting an application knew that if the application wasn’t up to snuff, the FDA would send it back. But those standards have fallen: “Now we send it back [only] if it’s really crappy.”
We also talked about direct-to-consumer advertising and why many in the pharmaceutical industry resisted the suggestion that they wait two years before trying to sell a new drug directly to the public. “There is a saying in the industry,” he confided, “[that] you want to get doctors accustomed to using a new drug while it still ‘works’—while it’s still the latest and the greatest.”
In other words, drug-makers want doctors to begin using the drug before everyone discovers that it is not quite the miracle cure that some hoped it would be. Knowing that it takes time to discover the risks of a drug, doctors might not be so quick to take up the absolute newest thing on their own. That’s why companies like to go to consumers who they hope will push their doctors into trying the new products before all the risks are known.
IF YOU’D LIKE TO
THIS POST, PLEASE
CLICK HERE TO E-MAIL MAGGIE WITH YOUR THOUGHTS.