SERVICES

SERVICES AND EXPERIENCE
PRESCRIPTION DRUGS AND BIOLOGICS

Based upon his nearly two decades of experience at Glaxo Wellcome, as well as upon his many years in private practice representing and advising pharmaceutical companies, Mr. Shapiro has developed an in-depth knowledge of the laws and regulations pertaining to prescription drugs and biologics.

Approvals

Mr. Shapiro has worked with scientific, medical and regulatory personnel to assist companies in preparing and filing new drug applications (“NDAs”), abbreviated new drug applications, (“ANDAs”), investigational new drug exemptions (INDs”) and biologic license applications (“BLAs”). A substantial portion of his practice is devoted to helping companies understand the applicable statutory and regulatory standards, develop approval strategies and navigate the approval process. He has also assisted companies in seeking and obtaining user fee waivers and exemptions.

Exclusivity

Mr. Shapiro has a wealth of knowledge and experience in all matters pertaining to new drug exclusivity under the Federal Food, Drug and Cosmetic Act, including the use of 505(b)(2) applications, Hatch Waxman new drug exclusivity, paragraph iv certifications, patent extensions, orphan drug designations, pediatric use exclusivity, and the use and filing of Citizen Petitions.

Compliance and Post-Approval Requirements

Much of Mr. Shapiro’s day-to-day practice involves advising companies on compliance and post-approval requirements, including matters pertaining to recalls, adverse event reporting, Dear Doctor letters, labeling and labeling changes, supplemental NDAs, good manufacturing practices, drug master files, clinical trial monitoring and bioresearch issues, and establishment registration and drug listings.

OTC DRUGS AND COSMETICS

Mr. Shapiro routinely advises companies on matters pertaining to labels, ingredient status, and packaging for OTC drugs and cosmetics and assists companies on product claims, OTC drug monograph issues and other matters pertaining to FDA regulation of OTC drugs and cosmetics.

MEDICAL DEVICES

Mr. Shapiro has assisted numerous companies on understanding and complying with FDA’s requirements for medical devices, including the use of Section 510(k) Premarket Notifications, Premarket Approval Applications (“PMAs”), investigational device exemptions (“IDEs”), Quality System Regulations (“QSRs”), device modifications, medical device reporting, corrections and removals, and recalls.

FOODS AND DIETARY SUPPLEMENTS

Mr. Shapiro assists companies in understanding the legal and regulatory requirements for marketing of conventional foods, dietary supplements, medical foods, and the regulatory status of various food ingredients. He also provides assistance in evaluating and developing labels and advertising for foods, including issues pertaining to health and nutrient content claims.

ADVERTISING AND PROMOTION

Mr. Shapiro has an in-depth knowledge of FDA’s regulation of prescription drug advertising and promotion. He has served as the legal reviewer on promotional material review teams at Glaxo Wellcome and for several clients while in private practice, and, in this capacity, has reviewed and approved literally hundreds of items of promotional materials for prescription drugs. While serving as Glaxo’s Washington, D. C. -based regulatory affairs representative, Mr. Shapiro was Glaxo’s point person for the Company’s interactions with the FDA’s Center for Drugs Division of Drug Marketing, Advertising, and Communications (“DDMAC”).

Mr. Shapiro also advises clients on the use of social media, direct to consumer promotion, websites, infomercials, press releases, First Amendment rights regarding off label product uses, and responding to unsolicited requests for information.

PRODUCT JURISDICTON AND COMBINATION PRODUCTS

The development and use of innovative new technologies often presents unique and challenging legal and regulatory questions regarding how FDA or other regulatory agencies regulate these new technologies. In some cases the technology might cross jurisdictional lines between two or more agencies. In other cases, the technology might fall within the jurisdiction of different Centers within the FDA, as, for example, in the case of a drug/device combination product. Mr. Shapiro assists companies in determining and negotiating these jurisdictional boundaries to bring these technologies to market.

TOBACCO

Mr. Shapiro has advised clients on the scope of the Family Smoking Prevention and Tobacco Control Act and its application or potential application to both tobacco and non-tobacco products.

HEALTH CARE FRAUD AND ABUSE LAWS

Mr. Shapiro frequently advises clients on the compliance of their sales and marketing programs practices with the Federal health care program antikickback law and related federal and state laws, the Federal False Claims Act and related federal and state laws, and state drug and device marketing prohibitions and reporting laws.

ENFORCEMENT AND COMPLIANCE

Mr. Shapiro has conducted internal investigations relating to potential compliance issues on a variety of matters and has advised and represented companies who are the subject of various enforcement activities, including inspections, FDA Form 483s, Warning Letters, seizures, injunctions, import/export detentions, subpoenas, and criminal investigations.

He has also represented clients in matters before various state boards, including the North Carolina Board of Pharmacy.

CORPORATE TRANSACTIONS

Mr. Shapiro frequently conducts regulatory due diligence reviews for companies engaged in a variety of corporate transactions, including licensing, mergers, acquisitions, and the like. He also frequently assists clients in considering the FDA-related implications of various commercial transactions and has provided advice and counsel on numerous commercial agreements, including supply distribution and manufacturing agreements.

CHILD-RESISTANT PACKAGING MATTERS

Mr. Shapiro routinely advises clients on the application of child-resistant packaging requirements under the Poison Prevention Packaging Act to prescription and OTC drugs.

TRAINING PROGRAMS

Mr. Shapiro has conducted training programs for numerous clients, associations and professional groups on a wide range of matters, including sales and speaker bureau training and the proper use of e-mails.

Please contact Mr. Shapiro if you would like to discuss a training program for your company or organization.

MEDIATION AND ARBITRATION SERVICES

Mr. Shapiro is a certified North Carolina Superior Court mediator and is available to provide mediation services to help resolve business and commercial disputes without having to resort to litigation, or to conduct settlement conferences in litigated matters.