Representative Engagements

Prescription Drugs & Biologics

♦  Secured FDA reversal of agency’s initial denial of 3-year exclusivity under Hatch-Waxman Act for OTC switch of drug previously available only via prescription. Involved detailed written submission to FDA on how law applied to factual scenario regarding client’s NDA for the Rx-OTC switch. 


♦ Spearheaded strategy to fight FDA’s proposed withdrawal of client’s abbreviated new drug application for unique topical drug product. Representation involved detailed written submission, including coordination with expert witnesses, securing drug’s continued marketing. 


♦  Developed overall strategy leading to filing and approval of New Drug Application (NDA) for innovative drug/device combination narcotic product for breakthrough cancer pain. 


♦ FDA counsel to major compounding pharmacy; led strategy to establish separate subsidiary to obtain formal FDA approval of specialty compounding formulations while maintaining compounding status. 


♦ Penned waiver requests under Pediatric Research Equity Act (PREA) as applicable to NDAs being filed by clients with innovative analgesic products being reviewed under FDA’s 505(b)(2) NDA process. 


♦ Coordinated all aspects of recall of pharmaceutical, including securing health assessment, drafting recall letters and press releases, and coordinating with FDA. 


♦ Secured issuance of FDA regulatory letter against brand name drug firm making improper comparative claims. 


♦ Led consortium of eight generic clients fighting FDA's withdrawal of new drug applications for generic versions of Persantine® (dipyridamole) allowing clients to remain on market.

Medical Devices & IVDs

♦  Coordinated major remediation effort for device maker facing systemic QSR deficiencies following FDA inspection and Warning Letter; effort led to FDA follow-up inspection with just a single observation. 


♦  Counseled on reclassification petitions for devices including under the FDA’s de novo process for down classifying devices involving new technology that are automatically classified in most restrictive device class (III), but can be regulated under controls applicable to Class II devices. 


♦ Construed applicability of Investigational Use Only (IUO) and Research Use Only (RUO) regulations to marketing of line of diagnostic products. 


♦  Secured release from FDA import detention for Canadian device manufacturer of devices allegedly misbranded by including claims outside allowed intended uses. Conducted detailed review of labeling claims, including website, Facebook and Twitter postings, to allow client to revise claims to enable it to reintroduce device into U.S. market. 

Compliance & Enforcement

♦  Coordinated major remediation effort for device maker facing systemic QSR deficiencies following FDA inspection and Warning Letter; effort led to FDA follow-up inspection with just a single observation. 


♦  Developed and oversaw operations of first corporate ethics program for generic drug firm as part of firm’s rehabilitation program following plea bargain for illegal activities of prior senior management. 


♦  Coordinated generic drug company's cooperation with federal criminal and congressional investigations leading to plea bargain agreement that allowed company to stay in business. 


♦  Negotiated agreement with Defense Logistics Agency successfully ending generic drug company's three-year suspension from federal government contracting. 


♦ Cleared import detention for importer of combination drug/device from China by conducting detailed label reviews and corrections to labeling.  

Clinical Research

♦  Prepared reply to warning letter issued to IRB resulting in IRB being able to continue operations without further FDA enforcement action.


♦  Wrote and negotiated numerous clinical trial agreements for sites in the U.S., China, and elsewhere.

OTC Drugs & Cosmetics

♦ Shepherded cosmetic company client through company-initiated recall.


♦  Detailed review and analysis of impact of FDA’s then new T.E.A. (Time and Extent Application) regulations for OTC drugs. 


♦  Secured imposition of import alert on gray market Dial® soap (on behalf of “real” Dial®) by showing FDA that foreign-made Dial contained color additives illegal in United States. 


♦ Intensive review of cosmetic product’s labeling and advertising claims to ensure not “drug” in nature, as well as assessment of comparative and other claims under FTC standards. 


♦ Prepared detailed comments on proposed change to FDA OTC Monograph on hydrocortisone products. 


♦  Defended OTC drug client’s advertising from competitor’s challenge before National Advertising Division (NAD) of Better Business Bureau. 


♦  Secured imposition of import alert on gray market Dial® soap (on behalf of “real” Dial®) by showing FDA that foreign-made Dial contained color additives illegal in United States.  

Import/Export Issues

♦  Secured imposition of import alert on gray market Dial® soap (on behalf of “real” Dial®) by showing FDA that foreign-made Dial contained color additives illegal in United States. 


♦  Cleared import detention for importer of combination drug/device from China by conducting detailed label reviews and corrections to labeling. 


♦ Coordinated response of Canadian device manufacturer to FDA detention of devices allegedly misbranded by including claims outside allowed intended uses. Conducted detailed review of labeling claims, including website, Facebook and Twitter postings, to allow client to revise claims to enable it to reintroduce device into U.S. market.     

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