Governance & Compliance

Life sciences companies seek our counsel for every facet of governance and regulatory compliance from new-product inception to international distribution. Squire Sanders comprehensive life sciences practice helps clients protect their interests, assists them in the development of policies and implementation of new regulations, and counsels them on compliance in these areas.

In addition to providing compliance counseling on laws specific to the healthcare and life science industries such as Medicare/Medicaid, HIPAA and other data protection issues, our lawyers are versed as counselors in providing guidance on the full range of compliance issues including:

• Advising pharmaceutical companies on Federal Communications Commission (FCC) matters regarding confidentiality and other regulatory issues associated with call centers.
• Advising hospital groups and life sciences clients concerning the Prescription Drug Marketing Act and the Robinson-Patman Act relative to group purchasing activities and the use of drugs purchased under such group purchasing plans in various clinic, ambulatory care and home healthcare settings.
• Advocating on behalf of industry clients in the legislative and administrative arenas.
• Representing client interests in various regulatory matters including state pharmacy law, Medicare/Medicaid fraud and abuse and other prescription regulatory matters.
• Representing pharmaceutical and biotechnology companies in disputes involving the FDA and FTC in the United States and before governmental bodies around the world.
• Handling FDA labeling and advertising matters involving cosmetic products.
• Advising companies on their obligations under REACH, the EU’s single, integrated system for the registration, evaluation, and authorization of chemicals.
• Dealing with the Prescription Drug Marketing Act, the Hatch Waxman Act, FDA regulatory compliance issues and antitrust litigation involving drug products for our clients.
• Providing advice and counsel, reviewing transactions and implementing compliance programs involving the Foreign Corrupt Practices Act (FCPA) and other similar regulations around the world.
• Advising on pricing and reimbursements in the United States, Europe and each of the EU Member States and the Commonwealth of Independent States.