PRESCRIPTION DRUG ABUSE
Hamburg downplayed suggestions that the agency might remove a heavily criticized painkiller from the market if a harder-to-abuse version becomes available. She said better abuse-deterrent formulas are needed to prevent abusers from chewing, snorting or injecting pain relievers to get high.
"We feel very strongly that the current technologies available are not adequate to truly turn the tide on the epidemic of abuse, and we need continuing advancement in the field of abuse-deterrent technology," Hamburg said.
The FDA has faced months of criticism from elected officials, law enforcement and anti-addiction groups for approving the powerful painkiller Zohydro last October. The long-acting opioid is the first U.S.-approved pure form of hydrocodone, the most abused prescription drug ingredient in the country. Previously it was only available in lower-dose combination pills like Vicodin.
Agency critics say the FDA should have required Zohydro to be formulated in a way that would make it difficult to abuse. And last month Purdue Pharma, maker of OxyContin, filed for FDA approval of its own crush-resistant hydrocodone tablet. The announcement raised questions about whether the FDA might remove Zohydro from the market if it approves Purdue's hydrocodone drug.
Hamburg said the agency needs to learn a lot more about what's in electronic cigarettes, how they work and how they are being used.
The FDA in April proposed regulating the popular battery-powered devices that heat a liquid nicotine solution, creating vapour that users inhale. The proposal would ban their sale to minors and require approval for new products and health warning labels.
Hamburg said there is still a lot of controversy over whether e-cigarettes are "a safer tool" that reduces nicotine addictions or whether they just "enable another form of tobacco and nicotine to be used by consumers to keep habits going."
— Calories on Menus. The food industry is closely watching the FDA to see which establishments are included in the final menu labeling rules, which are expected this year. Congress required the labels in 2010 health overhaul, and supermarkets and convenience stores have lobbied aggressively since then to be excluded. But the restaurant industry says that all establishments serving prepared foods should have to post the labels.
— Caffeine. Hamburg said the agency needs to better understand the role of the stimulant in non-traditional products, especially on children. She said the science is not absolutely clear about its effects.
The agency is investigating the safety of energy drinks and energy shots, prompted by consumer reports of illness and death. FDA is also looking at caffeine in food as manufacturers have added caffeine to candy, nuts and other snack foods in recent years.
— Genetically Modified Foods. Hamburg reiterated her support for voluntary GM labels, and said a "considerable amount of scientific study" does not suggest the kinds of public health concerns that some consumers have worried about. Advocates for GM labeling have been pushing state laws that require the labels.
As such, she says she does not believe FDA should have to do a mandatory safety review of all engineered foods. FDA now reviews the safety of GM animals, but has a voluntary review for companies that want to sell modified crops for consumption.
— Mercury in Fish. Hamburg says the agency soon will issue new advice for pregnant women on the appropriate levels of mercury in seafood, but not labels on seafood packages, as consumer groups have sought.
The advisory is a long-awaited move aimed at helping women better understand what to eat when they're pregnant.