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
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:
- Draft guidance for industry – “Good ANDA Submission Practices“
- Manual of Policies and Procedures (MAPP) – “Good ANDA Assessment Practices“
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