How outgoing FDA chief oversaw food, drugs and tobacco

AP News
|
Posted: Feb 05, 2015 2:10 PM

WASHINGTON (AP) — Food and Drug Administration Commissioner Margaret Hamburg announced Thursday that she will step down next month after nearly six years overseeing the agency, which regulates products making up 25 percent of the U.S. economy. During her tenure the FDA undertook major efforts to improve food safety, regulate tobacco and improve reviews of drugs. Here's a look at some of those efforts:

FOOD:

Under Hamburg, the FDA worked to implement sweeping food safety rules and proposed new nutritional information on food packaging and calorie information on restaurant menus. The agency also has given a definition to "gluten free" and taken a tough stand by pushing popular products that proved harmful off the market, like alcoholic energy drinks and caffeine gum.

Hamburg had the help of first lady Michelle Obama, who personally announced the efforts to revise the nutrition labels in an event at the White House last year. President Barack Obama pushed the food safety legislation, which Congress passed in 2010, after a widespread salmonella outbreak in peanuts.

The FDA's food reforms have sometimes angered food companies and farmers, who have pushed back. The safety rules would give the government new powers to inspect processing plants, order recalls and impose stricter standards for imported foods. It also requires stricter food safety standards on farms and in manufacturing plants, with the idea of preventing illness before it occurs, rather than responding after people get sick.

The rules mark the first time that FDA has broadly regulated farms for food safety, requiring farm businesses to make sure workers' hands are washed, irrigation water is clean and that animals stay out of fields, among other things. The agriculture industry said the rules FDA proposed in 2013 were too restrictive, so the agency revised them a year later.

Amid the industry pushback, some of Hamburg's early goals have been delayed, including voluntary guidelines for reducing sodium in foods, calorie labels on the front of packages and guidance on labeling genetically modified foods.

DRUGS

As pharmaceutical manufacturing increasingly moved overseas, the FDA under Hamburg tried to step up oversight of plants in Asia and other developing regions. Before Hamburg's arrival the agency was criticized for a spate of contamination problems with imported drugs, including a blood thinner from China linked to dozens of deaths and hundreds of allergic reactions. Hamburg made high-profile trips to India and China to enlist the cooperation of foreign officials, while also expanding the agency's own staff in those countries.

Over the last six years, the pharmaceutical industry resumed its perennial criticism about the pace of drug reviews. But the agency has kept up with its commitments, reviewing most regular drugs in about a year and priority drugs in under seven months. Hamburg highlighted the use of various programs to expedite approval of innovative drugs, including a "breakthrough therapies" program that has become popular with drug makers.

The agency still weathered harsh criticism for failing to catch dangerous drugs that sickened and killed patients. In 2012, Hamburg was called before Congress during a nationwide outbreak of deadly meningitis linked to contaminated steroid injections. Lawmakers blasted the FDA for failing to stop the manufacturer of the drugs, a Massachusetts specialty pharmacy that had been visited by both state and federal inspectors but never shut down. Hamburg emphasized the difficulty of overseeing these so-called compounding pharmacies, which had long operated in a legal gray area between state and federal regulations. In 2013 Congress passed a law giving the FDA clearer oversight of compounding pharmacies that produce medications in bulk.

TOBACCO

In 2009, the agency was granted authority to regulate the tobacco industry and assess available scientific evidence for what would best improve public health, though it cannot ban nicotine or cigarettes outright.

Since then the FDA has limited marketing, especially to children and has begun to look at the ingredients in cigarettes.

The agency also has launched a campaign to show the nation's young people the costs associated with smoking. It also is spending millions of dollars for research on tobacco products.

But legal fights with the industry have delayed plans to add graphic warning labels to cigarette packs. And despite multiple calls to action on electronic cigarettes from public health leaders and Congress, the agency has not yet finalized rules for the popular devices.

The agency has said its proposal last April sets a foundation for regulating the products, including banning sales to minors and requiring health warning labels, as well as approving new products. But the rules wouldn't immediately ban the wide array of flavors or styles of e-cigarettes, or curb marketing. There's no timetable for the final rules on e-cigarettes as well as other tobacco products like cigars.

In addition to the rules on e-cigarettes and cigars, the industry also is awaiting the agency's newest proposals for graphic warning labels, its recommendations on the use of menthol in cigarettes as well as reports to Congress due in April on the public heath impact of raising the minimum tobacco purchase age and how well the public understands the health consequences of using tobacco products.