“If you need a savvy counselor to your trade association, a skilled regulatory specialist with deep experience in the pharmaceutical and cannabis industries, or a national expert in drug supply chain and security challenges, I can advise you.”
- Washington, DC
- tpahl@ofwlaw.com
- (202) 518-6317
Tish is a highly experienced counsel to drug, cosmetic, dietary supplement, and food companies with matters before the Food and Drug Administration, the Federal Trade Commission, and other federal agencies. In addition to counseling FDA-regulated entities, she has particular expertise aiding trade associations in their compliance strategies and crafting advocacy on behalf of members and is a highly regarded expert and frequent speaker on pharmaceutical supply chain security and cannabis.
Counsel to with concerns before the FDA, FTC, and other federal agencies:
- Advise companies manufacturing and marketing human and animal prescription drugs, over-the-counter (OTC) drugs, homeopathic drugs, dietary supplements, and cosmetics
- Advise manufacturers and marketers on OTC monograph process and marketing pursuant to pending and final monographs
- Significant work with pharmaceutical supply chain stakeholders, including manufacturers, wholesale distributors, repackagers, dispensers and their respective trade associations on implementation of the Drug Supply Chain Security Act (DSCSA)
- Counseling regarding cannabis and cannabis-derivatives under the federal Food, Drug and Cosmetic Act and the 2018 Farm Bill
- Advise pharmacy compounders and outsourcing facilities on implementation of Title I of the Drug Quality and Security Act (DQSA)
- Prepare briefing documents to aid in public policy advocacy on behalf of FDA-regulated entities
- Advise on compliance matters, including internal investigations and responses to FDA inspections and warning letters
Counsel to trade association clients
- Monitor, review, and disseminate information concerning legislative, regulatory and policy developments to association staff and members
- Draft comments and advocacy pieces with association staff and members for submission to legal and regulatory authorities and policy makers
- Develop statutes and model regulations for consideration by legislative and regulatory bodies
- Attend association meetings as antitrust counsel and prepare minutes
- Provide general counseling to trade associations on communications, research activities, governance, contracts, bylaws, antitrust compliance, and other corporate matters
- Assist in subpoena compliance and litigation support
Regulatory Drafting Specialist
Frequent speaker on cannabis and DSCSA
Credentials
Education
Northwestern University, B.S.
Northwestern University, J.D., cum laude
Bar Admissions
District of Columbia
News & Insights
February 14th, 2017
2020
2020
