Proposed Rule Would Expand FDA’s Tobacco Control Authority

By: Margaret A. Hamburg, M.D.

Today we usher in a new chapter in FDA’s role in tobacco control, which began nearly five years ago when the Family Smoking Prevention and Tobacco Control Act enabled us to regulate certain tobacco products, including cigarettes and smokeless tobacco. Now, FDA has proposed a rule that would extend our authority to additional products meeting the legal definition of a tobacco product. This would include electronic cigarettes, some or all cigars, pipe tobacco, nicotine gels, waterpipe (hookah) tobacco and dissolvables not already under the FDA’s authority, as well as future tobacco products.

Margaret Hamburg, M.D.The tobacco product marketplace is evolving at a dizzying pace with many unanswered questions about the health effects of novel products. Especially in the shadow of alarming increases in the number of youths using unregulated products like electronic cigarettes and cigars, it’s more crucial than ever to help prevent early tobacco use that could lead to a lifetime of nicotine addiction. The proposed rule—which would “deem” other tobacco products to be subject to FDA authority—is poised to help make that happen.

FDA is committed to protecting public health. Expanding our authority over tobacco products gives FDA additional tools to help reduce the number of illnesses and premature deaths associated with the use of tobacco products. Under FDA’s proposal, these powerful regulatory tools would include age restrictions, rigorous review of new tobacco products and claims, and health warnings.

“Deeming” – and the new health warning requirements included in the proposed rule – would also help to correct a misperception by consumers that tobacco products not regulated by FDA are safe alternatives to currently regulated tobacco products. Equally important, “deeming” would allow FDA to issue future regulations regarding these products, including regulations to reduce their harmfulness, if we determine that would be appropriate to protect public health.

As we work to finalize the proposed rule, we welcome comments and will consider all that are submitted, as well as any data, research and other information submitted to the docket for this proposed rule.

For more information:

Margaret A. Hamburg, M.D., is Commissioner of the U.S. Food and Drug Administration

New Law Enhances Safety of Compounded Drugs and Protection of the Drug Supply Chain

By: Margaret A. Hamburg, M.D.

Since last year’s tragic meningitis outbreak and subsequent events involving compounded drugs, Congress has been hard at work to pass new legislation to provide FDA with the appropriate authorities for regulating compounded drugs to help make these products safe for the American public.

Margaret Hamburg, M.D.Over a much longer period of time, efforts have been made in Congress to enhance the security of the drug supply chain and protect consumers from exposure to counterfeit, stolen, contaminated or otherwise harmful drugs.

I am pleased that the Drug Quality and Security Act can help FDA protect public health in both of these critical areas.

One part of the new law offers a step forward in FDA’s oversight of certain entities that prepare compounded drugs. The new law will enable these compounders to register with the FDA to become “outsourcing facilities,” making them subject to certain other requirements including Federal quality standards, known as current good manufacturing practice. These facilities will also be subject to inspection by FDA on a risk-based schedule. If compounders register with FDA as outsourcers, hospitals and other health care providers will be able to provide their patients with drugs that were compounded in facilities that are subject to FDA oversight and federal requirements for current good manufacturing practice, among others. To that end, we will be encouraging healthcare providers and health networks to consider purchasing compounded products from facilities that are registered with FDA and subject to risk based inspections.

Drugs produced by compounders that are not registered as outsourcing facilities must meet certain other conditions described in the law, or they will be regulated by FDA as conventional drug manufacturers.

Generally, the state boards of pharmacy will continue to have primary responsibility for the day-to-day oversight of state licensed pharmacies, including traditional pharmacy compounding. And FDA will continue to cooperate with state authorities to address pharmacy compounding activities that may be in violation of the Federal Food Drug and Cosmetic Act.

Another part of the new law enables certain prescription drugs to be traced as they move through the U.S. drug supply chain. The goal is to protect the public from exposure to counterfeit, stolen, or otherwise harmful drugs. This will require manufacturers, repackagers, wholesale drug distributors, and dispensers (other than most licensed health care practitioners) to provide product and transaction information with each sale and notify the FDA and other stakeholders of illegitimate products, which will result in improved detection and removal of potentially dangerous drugs from the supply chain.

Starting four years after enactment of the law, manufacturers, followed by repackagers, will be required to affix a unique product identifier to each drug package that contains the drug’s national drug code (NDC), serial number, lot number, and expiration date. Starting six years after enactment of the law, wholesale drug distributors, followed by dispensers, may only trade products that  are encoded with product identifiers and will be able to verify the product identifier if they determine that they have  suspect product. Ten years after enactment, supply chain stakeholders and FDA will benefit from an electronic, interoperable system which will facilitate the efficient exchange of product and transaction information for prescription drugs at the individual package level. The system, when fully implemented, will enable verification of the legitimacy of the drug product identifier down to the package level, enhanced detection and notification of illegitimate product, and improved efficiency of recalls.

The Drug Quality and Security Act is a significant step toward having new and stronger drug quality and safety laws. While the law does not provide FDA with all the additional authorities sought, these provisions are a sign of progress.

We are committed and prepared to implement the new law that will help us to further protect public health.

Margaret A. Hamburg, M.D., is the Commissioner of the Food and Drug Administration