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Khelin Aiken supports life sciences companies as they develop innovative products and bring them to market, with particular focus on therapeutic product development plans and marketing applications for prescription drugs, including therapeutic biologics and generics. She also advises on policies related to over-the-counter (OTC) drugs. Prior to joining McDermott, Khelin served as regulatory counsel at the Food and Drug Administration (FDA) in the Center for Drug Evaluation and Research, first in the Office of Regulatory Policy, and most recently in the Office of New Drugs with the Therapeutic Biologics and Biosimilars Staff. Read Khelin N. Aiken's full bio.

The Food and Drug Administration (FDA) has communicated a commitment to ensuring that firms marketing dietary supplements are not misleading particularly vulnerable consumers (e.g., elderly, cancer patients, or children) with baseless disease treatment or prevention product claims. Prior FDA leadership was vocal about the need to closely monitor the dietary supplement industry because of the significant footprint the industry has established. Couple the bustling supplement industry with the awakening cannabis and cannabis derived industry, and there is colossal business opportunity. The opportunity, however, must be married with measured restraint, particularly in advertising and marketing claims.

Trailing the 2018 Farm Bill, FDA is pushing forward with its information-gathering efforts to determine if it will embark on a rule making process to allow the marketing of cannabidial (CBD) as a dietary supplement. Currently, dietary supplement products containing CBD cannot be legally marketed in the United States. As previously explained, under current federal law, marketing is prohibited because CBD is an active ingredient in an FDA approved drug that was the subject of substantial clinical investigations.

On July 22, Curaleaf Inc., a Massachusetts firm, received a warning letter from the FDA, citing the company for marketing products containing CBD (i.e., CBD lotion, pain-relief patch, tincture and vape pen) in violation of the Food Drug and Cosmetic Act (FD&C Act). Curaleaf operates online and has dispensaries in 12 states. The company markets medical marijuana and sells dietary supplement products containing CBD derived from hemp, under its Curaleaf Hemp brand and Bido brand for pets. This is the fourth letter this year that the agency has issued to a firm that markets products containing CBD. The Agency’s letter identified a number of statements from Curaleaf’s website that FDA says establishes that the “products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body.” The FDA specifically called out product claims and social media promotion that touted these products as treating Alzheimer’s disease, anxiety, depression, cancer, opioid withdrawal and Parkinson’s disease. Curaleaf was also cited for marketing CBD products for use in pets that suffer from arthritis and pain associated with aging.

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In 2016, Congress passed the 21st Century Cures Act (Cures Act), which contained provisions to help accelerate medical product innovation while reducing regulatory burden, as well as to increase efforts for critical research and increase the involvement of patients and their perspectives in research and the product development process. The Cures Act specifically provided the US Food and Drug Administration (FDA) authority to modernize product development and review, and create greater efficiencies and predictability in product development and review. In June 2018, in response to this congressional mandate and corresponding new authorities, as well as reauthorizations of FDA’s user fee agreements, FDA made a series of announcements for a proposal to modernize new drug development.

Highlights of FDA’s initial proposal included:

  • Focusing on recruiting talent across disciplines;
  • Building multidisciplinary teams for more efficient collaboration;
  • Prioritizing operational excellence through a single and consistent review process;
  • Improving knowledge management through enhancements to information technology and honed expertise within review divisions;
  • Emphasizing safety and risk-benefit analysis before and after approval; and
  • Incorporating the patient voice into product development.

As articulated by former FDA Commissioner Scott Gottlieb, “[a] principal aim of these proposed changes is to elevate the role of . . . scientists and medical officers to take on even more thought leadership in their fields.”  The agency contemplates implementing organizational and structural changes that make drug review divisions more therapeutically-focused to promote efficient review and transparency in – as well as patient and stakeholder access to – the review process. According to the agency, these and other changes that are part of the Cures Act will result in a 20 percent improvement in efficiency.

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