- That time of year is fast-approaching, and the Food and Drug Administration is looking ahead to its policy goals for 2018. The agency is declaring its major policy goals for 2018, as part of its twice-yearly Unified Agenda of Federal Regulatory and Deregulatory Actions.
- The agency's key areas of focus over the next year, as announced by FDA Commissioner Scott Gottlieb, will include targeting nicotine addiction, improving and promoting drug and food safety, and modernizing standards.
- One of the broader goals is to encourage people to make better choices about their lifestyle and health in order to help prevent disease.
"[The Food and Drug Administration] serves Americans by delivering on the critical mission of protecting and promoting the public health. The more than 70 actions we have identified, as part of the Fall 2017 Unified Agenda, will help us even better deliver on this mission," wrote Gottlieb on the agency's blog FDAVoice.
Cigarette smoking in the U.S. is one of the leading causes of preventable disease and death, according to the Centers for Disease Control and Prevention. Around 15% of the U.S. adult population smoked cigarettes in 2015. Smoking is behind around one in every five deaths, and around 15 million people in America live with a smoking-related disease.
To tackle this, The Food and Drug Administration is looking at reducing the nicotine levels in combustible cigarettes in an effort to reduce or even eliminate their ability to cause addiction. In parallel with this, the agency is also encouraging innovation into products and devices that can deliver satisfying levels of nicotine at lower risk. In another approach, the FDA plans to investigate regulating flavors in tobacco products to reduce their attraction to younger people.
Drug compounding – therapeutics that are prepared by pharmacists or physicians – are a way that patients can receive drugs that are tailored to their particular needs, for example in a liquid formulation or without an ingredient that could trigger an allergic reaction. However, there may be risks associated with these FDA-unapproved drugs, and the FDA plans to put in place regulations that will ensure their quality.
Drug development is a costly and demanding process. Making regulations more efficient and better defined, and ensuring that they follow current science, will help smooth the process and speed drugs to the market, while protecting patient safety. As an example, Gottlieb has announced that the FDA is moving towards increased acceptance of electronic submissions, and is removing outdated inspection provisions for biologics and drug sterilization techniques.
Providing clear, concise and well-written information on drugs helps patients take control of their healthcare, make the right decisions, and take their drugs correctly. The FDA has proposed a new type of patient medication document that will meet these needs. The agency is also looking at expanding the scope of drug products that can be made available without prescription, perhaps through the use of mobile apps for screening questions.
As well as changing regulations, the FDA is planning other approaches to change through 2018.
"Over the next year, we will also tackle many additional priority areas through guidance documents and other policy efforts. These areas will include efforts to reduce the cost of drugs by encouraging competition, spur innovation across medical products, give consumers access to clear and consistent nutrition information, create greater regulatory efficiencies in bringing products to market, and put a dent in the opioid addiction crisis facing our country," said Gottlieb.