Our international Life Sciences Team has diverse experience when it comes to providing regulatory compliance counseling to clients in the health care and life sciences industry. We have represented clients in matters involving the FDA, various business threats, regulatory and legislative support, legislation and funding, fraud and abuse, and privacy laws and HIPAA. Our attorneys have counseled clients on a wide range of specific issues, including in relation to clinical trial authorizations, marketing authorizations, advertising, product recalls and regulatory diligence in preparation for acquisitions. Our regulatory lawyers also have successfully opposed an MHRA decision to withdraw permission for a clinical trial. In Europe, our attorneys regularly advise clients on the regulatory requirements imposed by European law, and by the national jurisdictions in which they operate.
FDA and Other Regulatory Counseling
Our regulatory team provides key access to FDA and other decision-makers. We advise companies on INDA; NDA; ANDA; IDE; PMA; 510(k) applications for regulatory approval/ clearance for drugs, food products, biologics and medical devices; product recalls; promotion and labeling; and FDA-related import and export requirements. We perform compliance audits and assist with investigations. Our life sciences clients call upon us for advice concerning orphan drug designation and fast-track review, food additive petitions, labeling and advertising copy, Internet compliance, citizens' petitions and FOIA requests, clinical trial agreements, and related matters before the Federal Trade Commission.
Business Threats
When the FDA threatened our client's tissue-bank business by reclassifying its primary product into a category that could greatly extend the regulatory approval timeframe, we acted quickly – convincing the FDA to revise its position and thereby allow the product to reach the market.
Comprehensive Regulatory Support
We helped an oncology-focused pharmaceutical client draft documentation in compliance with FDA requirements, including regulatory opinions for public offerings, and investigator, grant, and patient recruiting agreements. We guided the company through a compliance audit of the company's holdings held by its principle investigator to avoid financial conflict-of-interest disclosure to the regulator. And, we are working to obtain orphan drug designation for a bladder cancer treatment.
Fraud and Abuse
We help clients stay on top of fraud and abuse, anti-kickback, Stark and safe harbor laws, identifying the potential risks arising from marketing, sales and pricing programs.
Our attorneys recommend compliance procedures, conduct training, and perform audits to prevent enforcement actions and penalties. We have obtained advisory opinions that help companies manage risk and structure business initiatives with a better understanding of federal enforcement intentions.
Reed Smith's attorneys stand by clients faced with civil and/or criminal investigations, helping to negotiate settlements and defend clients in government and qui tam (whistleblower) litigation, and to implement corporate integrity agreements.
Privacy Laws and HIPAA Advice
In the United States, we have helped pharmaceutical companies, device manufacturers and blood banks determine how HIPAA affects their businesses, and have drafted and implemented business associate contracts to comply with HIPAA. We were chosen by the Healthcare Leadership Council and the members of its broad coalition on patient privacy to develop an online, comprehensive, 50-state study of privacy rules and their relationship to HIPAA. The study was funded by top life sciences and health care entities.
In Europe, we have carried out audit programs for compliance with data protection rules applicable in different countries, including in relation to clinical data and information. Following such audits, we are able to provide a tailored compliance program and are able to assist with implementation. We also regularly draft contracts in compliance with data protection rules.