Health Care: Pharmaceuticals

Our FDA practice is broad-based, but with a particular emphasis on challenging drug, biologic and medical device matters. Our capabilities include but are not limited to:

• All aspects of drug and biologic regulation.
  
  
• All aspects of medical device and diagnostic product regulation.
  
  
• Labeling matters for pharmaceuticals, medical device and dietary supplements.
  
  
• Promotion and advertising matters for pharmaceuticals, medical device and dietary supplements.
  
  
• Claims under the Dietary Supplement Health and Education Act of 1994 (“DSHEA”).
  
  
• Managing and responding to agency inspections and Form 483 citations.
  
  
• Quality assurance and pharmacovigilance matters and recalls.
  
  
• Assisting our medical device, pharmaceutical, biologic and biotechnology clients on questions involving clinical trial strategies and compliance, including Good Clinical Practices, Institutional Review Boards and patient informed consent.
  
  
• Good Manufacturing Practice and Quality Systems Requirements, including assisting in third-party audits and drafting SOPs.
  
  
• Clinical Laboratory Improvement Act compliance.
  
  
• Drafting and negotiating clinical trial, laboratory services, manufacturing, labeling, advertising and supply agreements, as well as handling other issues that arise during a product’s progression from pre-market clinical testing to post-market commercial distribution.

In addition, our attorneys advise our clients on FDA import and export laws, including importation of bulk substances, importation of finished products and the legal pitfalls associated with the so-called “personal use” importation exception. Our attorneys closely follow and understand the laws governing the manufacturing, advertising, marketing and labeling of prescription drugs, including advertising for off-label uses. As illustrated in Section C, group members regularly advise clients on the laws governing the advertisement of prescription drug prices and reminder advertising, and the recent developments in direct-to-consumer drug advertising.

DEA

Because our regulatory and compliance attorneys have represented drug manufacturers, pharmacies, hospitals, physicians and other entities holding DEA licenses, group members have extensive experience in helping clients comply with DEA requirements for controlled substance distribution and prescription dispensing. Our attorneys have defended clients that have lost significant quantities of controlled substances and performed investigations to determine the source of the loss to assist these providers in developing new procedures to reduce further loss. In addition, we have assisted national clients that hold nonresident pharmacy licenses in each of the states that require such licensure to comply with state reporting requirements for Schedule II controlled substances.

For more information on how our FDA/Regulatory Team can assist you, please contact Roger Morris at  / (602) 229-5269 or your local Quarles & Brady attorney.