Education
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University of Pennsylvania Law School, J.D., cum laude, 1992
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Wharton School of the University of Pennsylvania, B.S., magna cum laude, 1989
Bar Admissions
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District of Columbia
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Pennsylvania
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Paul Rubin represents clients regulated by the Food and Drug Administration (FDA), Federal Trade Commission (FTC), Consumer Product Safety Commission (CPSC) and other regulatory agencies at both the federal and state level. He is Deputy Chair of the firm's FDA Practice Group and heads the firm’s Transactional Risk Assessment Practice Group, where he provides due diligence on corporate transactions and private equity investments. Mr. Rubin represents client interests in the U.S. Congress and federal agencies.
Mr. Rubin’s practice is both proactive, providing strategic regulatory counseling and reactive, responding to regulatory enforcement actions. This often involves responding to FDA Warning Letters, FTC access letters, product seizures, import alerts and detentions, recall requests, inspection disputes and injunctive and criminal actions.
Mr. Rubin’s practice includes advising clients regarding FDA-related regulatory submissions such as NDAs, 510(k)'s, PMAs, GRAS notifications (for conventional foods, functional foods and medical foods), Health Claim/Qualified Health Claim petitions, Citizen Petitions and New Dietary Ingredient (NDI) submissions. He also advises clients on CPSC-related submissions, including Section 15(b) submissions and “Fast Track Recalls.” He also routinely counsels clients regarding product liability issues and export and import-related matters, including issues arising under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the “Bioterrorism Act”). He also frequently counsels clients and prepares submissions in accordance with the Data Quality Act.
A substantial portion of Mr. Rubin’s practice involves counseling clients on advertising and promotion-related issues, and representing clients before the FTC’s Bureau of Consumer Protection and the National Advertising Division of the Better Business Bureau (NAD). This includes representation of companies and individuals subject to FTC enforcement. Mr. Rubin has also represented numerous clients involved in Lanham Act disputes and under state investigation for alleged false advertising or Unfair and Deceptive Acts and Practices (UDAP) violations.
Representative Matters
FDA
- Represented drug company in FDA investigation related to deaths allegedly associated with bulk ingredients imported from China.
- Represented FDA-regulated company under congressional investigation related to assorted promotional issues.
- Represented drug company targeted by a “short-seller” in communications with the FDA.
- Represented drug company in addressing pharmacy compounding of its orphan drug product.
- Routinely prepares 483 responses for FDA-regulated companies, and responds to FDA enforcement actions (including Warning Letter response letters).
- Represented a food/dietary supplement ingredient supplier in lawsuits involving fraud allegations based upon ingredient purity/content.
- Counseled dietary supplement company subject to FDA and congressional scrutiny associated with adverse events.
- Advises numerous drug companies regarding compliance with OTC Drug Review.
- Advises numerous drug companies on DDMAC compliance issues.
- Represented dietary supplement company in precedent-setting FDA enforcement action based upon alleged inclusion of a drug ingredient in a dietary supplement, pursuant to the DSHEA “exclusionary clause.”
- Counsel to many food/dietary supplement companies regarding congressional food safety reform initiatives.
- Represented company before Congress and FDA regarding appropriate regulation of cosmetic appliances.
- Represented drug company in submission of extensive comments addressing reimportation of prescription drugs.
- Advises clients regarding FDA implementation of the Family Smoking Prevention and Tobacco Control Act and regulatory filings.
- Represents medical device companies in challenging gray market and related devices that pose consumer safety issues.
- Advises clients on emerging “social media” regulatory issues.
- Advises companies on Hatch/Waxman Act issues and drafts related Citizen Petitions.
- Counsel to numerous companies in drafting new dietary ingredient submissions to FDA.
- Represented coalition of drug companies in successfully reversing Customs’ import duty applicable to certain medicaments.
- Counsel to companies in arbitration based upon disputes over FDA-related language in licensing agreements.
FTC/NAD
- Successfully defended food, dietary supplement, OTC drug companies, and individuals under FTC investigation for unsubstantiated claims.
- Represented large national retailer subject to FTC investigation for alleged failure to comply with consumer protection statute, resulting in public closing letter.
- Represented health care communication company in obtaining FTC authorization under Telemarketing Sales Rule to place prerecorded calls authorized pursuant to the Health Insurance Portability and Accountability Act (HIPAA).
- Counsel to major jewelry associations and submitted petitions and extensive comments regarding FTC jewelry guides.
- Counsel to many companies regarding environmental “green claims.”
- Counsel to advertising agencies and infomercial companies regarding assorted compliance issues.
- Successfully defended many FDA-regulated companies in NAD challenges and successfully initiated NAD challenges against competitors.
CPSC
- Represented company engaged in one of the largest CPSC recalls in the history of the agency, involving more than 25 million products recalled at consumer level.
- Successfully defended company against CPSC challenge regarding appropriate age-grading of consumer products.
- Routinely submit 15(b) filings with the CPSC and coordinate product recalls on behalf of numerous consumer product companies and retailers.
- Advising numerous companies on compliance with the Consumer Product Safety Improvement Act of 2008 (CPSIA).
Transactional Work
- Represent numerous private equity funds in conducting regulatory due diligence on corporate transactions. Due diligence projects frequently include assessment of ongoing or projected congressional and regulatory initiatives.
- Routinely conduct due diligence on FDA-regulated companies.
- Lead regulatory counsel in multibillion dollar transaction involving federal and multistate regulatory due diligence and license transfers.
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