FDA News and Views: CDER standards program, Anti-aging Products, Enhancing Generic Drug Review and Availability, Smoking Cessation Products – Drug and Device Digest

FDA BRIEF: Week of Jan 1, 2018


CDER Data Standards Program Action Plan

Governing body for drug data standards

  • Provides quarterly updates on  current initiatives

Program Initiatives

  • Drug Development and Pre-Market Review
  • Drug Safety Performance and Promotion
  • Pharmaceutical Quality
  • Policy


Examples of claims cosmetics are allowed to make: Cleanses skin, Enhances beauty, Promotes attractiveness, Alters appearance. Examples of claims cosmetics may NOT make: Treats a disease, such as acne, eczema, or rosacea; Increases collagen; Revives cells.

Wrinkle Treatments and Other Anti-aging Products

Cosmetics – if:

  • Intended to make people more attractive e.g. moisturizing
  • Intended to make lines and wrinkles less noticeableby moisturizing the skin
  • Makeup or “primers” intended hide signs of aging
  • Must be safe when used according to product labeling
  • Does not require cosmetics to be approved by FDA

Drugs or Medical Devices – if:

  • Intended to affect the structure or function of the body, such as the skin
  • To remove wrinkles or increase the skin’s production of collagen
  • Will require marketing authorization by FDA based on effectiveness and safety

FDA concern: Product claims, marketed as cosmetics (skin care, anti-wrinkle, anti-aging) that involve supposed effects on the structure or function of the skin



Statement from FDA Commissioner Scott Gottlieb, M.D. on new steps to facilitate efficient generic drug review to enhance competition, promote access and lower drug prices

Continued implementation of the “Drug Competition Action Plan”

  • Reducing gaming by branded companies that can delay generic drug entry
  • Resolving scientific and regulatory obstacles to generics approval
  • Improving efficiency and predictability of  FDA’s generic review process

Releasing 2 documents:

Additional Steps:

  • Improve FDA practices and efficiency
  • Accelerate generic entry of complex generics e.g. metered dose inhalers
  • Take steps to minimize brand companies tactics to deter generics

Potential abuses of the citizen petition process

Restricting access to testing samples of branded drugs

Abuses of the single, shared system REMS negotiation process



FDA-approved smoking cessation products

Nicotine Replacement Therapy (NRT)

  • Nicotine primarily responsible for causing addiction
  • NRTproducts designed to wean smokers by supplying nicotine in controlled amounts while sparing from other chemicals found in tobacco products
  • Short time use to manage nicotine cravings and withdrawal
  • Available over the counter and by prescription

Over-the-counter NRTs 

  • Skin patches (also called “transdermal nicotine patches”)
  • Chewing gum (also called “nicotine gum”)
  • Lozenges (also called “nicotine lozenges”)
  • Important to follow the instructions on the Drug Facts Label (DFL) and User’s Guide

Prescription nicotine replacement therapy (prescription): Nicotrol

Smoking cessation products that do not contain nicotine (prescription): Chantix (varenicline tartrate) and Zyban (buproprion hydrochloride)



Image credit: FDA


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