Tobacco, Food, eMDR, Transparency, More Staff Add Up to a Big 2009 for FDA – and 2010 Looks Even Bigger
The early part of the 21st century was a tough time for the FDA. Its budget was curtailed, it lost some important personnel, and the word “acting” kept appearing on people’s business cards.
But 2009 just might be going down in history as the Year of the FDA Turnaround.
In October, the agency announced a long-overdue hiring binge that signals an even stronger FDA is on tap for 2010.
Watch for the agency to get a bigger budget in the coming years – though much of that emphasis will be on the food side and perhaps less on the drug and device side. For FY 2010, the FDA requested a total budget of $3.2 billion. This amount is $511 million more than FY 2009 and represents a 19 percent increase — the largest ever in FDA history. They won’t get it all, but they’ll probably come close.
Here are some other FDA highlights in a big year:
FDA Finally Gets Tobacco
It took years of lobbying and a new President, but in June 2009 the FDA was given the power to regulate tobacco products. This is a huge victory for the agency. It remains to be seen how the FDA will use this new power, but its surge of activity in the second half of 2009 suggests they want to seize the initiative.
Lawrence Deyton, M.S.P.H., M.D., joined the U.S. Food and Drug Administration (FDA) on Sept. 14, 2009, as director of the agency’s new Center for Tobacco Products. He hit the ground running.
“Our objective is to use the best available science to develop and put into action effective public health strategies to reduce the enormous toll of illness and death caused by tobacco products,” Deyton said .
Deyton was also asked how the tobacco regulation differs from FDA’s regulation of drugs or medical devices?
“FDA’s regulatory role for drugs and medical devices is usually based on a safety and effectiveness standard. The tobacco act establishes a new standard: to regulate tobacco products based on a public health and population health standard.
Deyton noted that when FDA gets an application for a new drug to treat a disease, the agency normally considers studies of patients who have the disease. ”But when we get an application for a new tobacco product, the law tells us we have to consider whether permitting the product’s marketing protects the public health and we have to evaluate the effects of the product on the population as a whole. We’re directed to consider both users and nonusers, and whether our action might encourage people who don’t use tobacco products to begin using them, or encourage people who might otherwise quit to continue using them.”
Bottom-line: It was a huge turf battle victory for the FDA and increases the agency’s overall regulatory clout.
Risk Communications
The agency also took big strides forward in how it gets the word out to industry and the public regarding risk. In its Strategic Plan the agency spelled out its perceived role in communicating the risks of regulated product use, defining risk communication anew for a 21st century in which evolving technologies have enabled increased patient and consumer involvement in managing their health and well-being. The document defines the three key areas (science, capacity, and policy) in which strategic actions, in collaboration with relevant domestic and international stakeholders, can improve the generation, dissemination, and regulation of risk communication about regulated products. It also identifies and details 14 specific strategies.
“FDA is showing its commitment to the goals of the plan not just by identifying the strategies it will implement, but also by identifying over 70 actions the agency plans to take within the next few years to improve risk communication,” it says in the Strategic Plan. The document also identifies 14 of those actions that FDA plans to accomplish within the next 12 months.
Clearing Up Transparency
Echoing an Obama campaign promise to make government more open and accountable to taxpayers, the FDA also walked the walked and talked the talk with its new “transparency” initiative with public meetings in June and November. The agency also opened a blog that, so far, has had a fair amount of uncensored comment both pro and con about agency performance.
Here (Finally) Comes the eMDR Guidance
In August, the FDA unveiled their proposed guidance for ultimately mandating electronic submission of mandatory adverse event reports. It took a long time to come to fruition, and some are lobbying the agency to push it back another year or two, but the simple fact that it was released was a big deal in 2009.
Guidance on Presenting Risk Info
Before unveiling the eMDR rule, the agency also issued in May the important draft Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion. The guidance is important on several levels, but perhaps the most important is that it addresses factors the FDA considers when evaluating ads and promotional labeling for prescription drugs, ads for restricted medical devices, and promotional labeling for all medical devices for their compliance with the Federal Food, Drug, and Cosmetic Act and relevant regulations.
In doing so, it cleared up a lot of confusion in the industry and signaled a revitalized FDA that was on the way back.
Putting The ‘Food’ Back In Food & Drug Administration
Responding in part to pressure from Congress and consumer groups over beef and other food contamination recalls, the FDA also revitalized its food enforcement in 2009, and this is also an area where the smart money says they’ll be even more active in 2010. In September, the agency capped a number of new food initiatives by unveiling a new reporting system that gives the agency new enforcement teeth when it comes to the food chain.
Here’s a prediction: FDA historians of the future are probably going to see 2009 as the year the agency picked itself up off the ground and started to flex its regulatory muscle again.
