FDA names opioids, drug competition as top 2018 policy goals


The U.S. Food and Drug Administration plans to focus on reducing opioid misuse

and promoting drug competition as two of its top policy priorities for 2018.

In a list released Thursday, the agency also said it wants to strengthen its scientific workforce and use nutrition to reduce the burden of disease this year.

FDA Commissioner Dr. Scott Gottlieb said the priorities represent the agency’s collective efforts to address public health. “Each one of us has an important role to play in achieving this mission,” he said in a statement.

The opioid crisis was the driver behind another record-setting year for drug overdose deaths in 2016, climbing by 21% over 2015 to nearly 64,000, according to the Centers for Disease Control and Prevention.

One of the actions the FDA plans to take to combat the epidemic will be reassessing how the agency evaluates opioid products before and after they reach the market, including consideration of the risk for misuse. On Thursday, the agency placed new restrictions on the use of opioids in children’s cold and cough products. In June, FDA requested Endo Pharmaceuticals remove its opioid pain medication, Opana ER, from the market due to its potential risk for abuse.

FDA will also encourage drugmakers to develop new abuse-deterrent opioid formulas and medication-assisted treatments. The agency will finalize policies to allow pharmacies to sell the overdose-reversal drug naloxone over the counter, an idea the FDA previously proposed during the Obama administration.

In terms of generics, the FDA wants to streamline the regulatory approval process and bring the lower-priced drugs to the market quicker. FDA will launch a program to promote biosimilar drug development as well.

“By making sure that the barriers to generic entry are not unnecessarily inflated through outdated scientific standards or inefficiencies in the development process — while maintaining the FDA’s gold standard for quality, safety and effectiveness — the agency can help lower the barriers to generic entry, keep costs low for high-quality generic products, ensure an adequate supply of critical generic medicines and promote price competition,” the FDA roadmap said.

FDA also set a goal to reduce preventable disease caused by poor nutrition, which affects approximately half of all American adults and has led to a steady rise in cases of cancer, heart disease and diabetes over the past two decades. The agency will move forward with menu labeling regulations to take place after years of delays.

The rule, finalized in 2014 but not yet implemented, would require chain restaurants, grocery stores and convenience stores to include calorie counts of the food items they serve on menus.

But strong pushback by the restaurant industry led to delays in when the rule would to go into effect. In June, consumer health advocates sued the FDA over the rule’s implementation, and the agency ultimately issued draft guidance last November for industry on how to comply with the menu labeling requirements by May 2018.

Gottlieb said the plan was not intended to be an exhaustive list of items the agency plans to set its focus, but rather an effort to be more transparent on its major goals for the year.

“These goals — and the work we do together in achieving them — go to the heart of our mission of advancing and protecting public health, while maintaining our commitment to the scientific standards that make FDA a recognized global leader, and a gold standard for product review,” Gottlieb said

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