The economic pressures that are placed upon the pharmaceutical industry as a result of competition, increased reporting requirements, research and development pressures and regulatory compliance have resulted in a very aggressive strategy by some companies when it comes to promoting their products. When a consumer reads, views or hears claims about a drugs application or efficacy the consumer is led to believe that these claims are supported and sanctioned by the FDA. Very often this is not the case.
According to a new report published in Forbes magazine, the FDA has taken a much more aggressive posture since Pres. Obama came into office. According to Forbes,Thomas Abrams, who heads up the FDA division that oversees drug marketing, freely admits it. His group sent 41 enforcement letters in 2009, up from just 21 the year before. And so far this year–just the month of January–it has dispatched another nine, with plans to continue that pace through 2010.”We’re trying to get the point across to industry that we want them to comply with the law because it affects public health,” Abrams says in an interview with Reuters. “If you don’t comply with the law, we are going to take action. We are not going to tolerate having consumers or healthcare professionals misled.”
It’s not unexpected, considering that FDA Commissioner Margaret Hamburg has pledged to increase the agency’s enforcement presence. And she’s promised to streamline processes that slowed down regulatory action. That streamlining has already had an effect at DDMAC, Abrams said; his division has changed its procedures so that warning letters go out more quickly. “We are inspired by Dr. Hamburg’s enforcement initiative and have taken it to heart,” he told the news service. “I personally am thrilled with it.”
This updated surveillance is good news for the consumer.