Julie Tibbets is a partner in the firm's Food, Drug & Device/FDA Group. Julie focuses her practice on assessing regulatory advantages and risks and advising clients on compliance with various laws and regulations, including those administered by FDA, DEA, FTC, USDA and related state authorities. She counsels manufacturers and distributors of FDA-regulated products, including drugs, biologics, medical devices, foods, dietary supplements and cosmetics in addition to counseling marketers of these products and health care providers. Her areas of expertise include advising clients on: product labeling, advertising, marketing claims and employee training materials; company interactions with health care professionals; continuing medical education programs; product recall strategies; adverse event reporting; product formulations/ingredients; the resolution of establishment inspection deficiencies; and controlled substance diversion/loss reporting. Julie has been selected by Super Lawyers as a 2013 Washington, D.C. "Rising Star."
- Counsels the internal materials review committees of biologic, drug and device companies on the promotion and advertising of their products, including recombinant protein-based injectables, contrast agents, medical imaging equipment and hemostatic patches.
- Advises drug, biologic, device and clinical laboratory companies on the application of Sunshine Act reporting requirements to their businesses.
- Conducts FDA regulatory due diligence reviews of food, drug, device and dietary supplement companies and advises clients on the regulatory risk profiles of companies subject to pending acquisitions and mergers.
- Represents a food manufacturer and retailer on compliance with and implementation of the requirements of the FDA Food Safety Modernization Act and menu labeling.
- Advises manufacturers, laboratories and health care providers on state compounding laws and regulations triggered by activities and implications of federal legislative proposals on business operations.
- Advises a university hospital on the DEA and state reporting requirements for the diversion or loss of controlled substances.
- Assists food, dietary supplement and cosmetic manufacturers with new product launches, including review of product labeling and marketing claims.
“The Final Word on Drug Sample Reporting: Coming Soon?” Pharmaceutical Compliance Monitor, March 11, 2013.
March 11, 2013
On January 22, 2013, the U.S. Food and Drug Administration (FDA) published its final rule implementing current good manufacturing practice (CGMP) requirements for combination products, which will take effect on July 22, 2013. FDA promulgated the rule in response to comments the agency received on its CGMP Guidance for Combination Products that described the need to develop a clear regulatory framework to account for the variety of combination products that can contain drug, device and/or biologic components.
January 24, 2013
On December 31, 2012, FDA issued two guidance documents detailing the agency’s approach to reviewing the completeness of medical device applications reviewed by the Center for Devices and Radiological Health (CDRH). The two guidance documents cover PMA submissions, Acceptance and Filing Reviews for Premarket Approval PMAs) (“PMA Guidance”), and 510(k) submissions, Refuse to Accept Policy for 510(k)s (“510(k) Guidance”). Both of these documents superseded previous FDA guidance on evaluating whether medical device applications were complete for filing.
January 14, 2013
This special edition of The FDA Monitor discusses the recent Second Circuit decision in United States v. Caronia.
December 11, 2012
With the reelection of President Obama, the U.S. Food and Drug Administration (FDA) is likely to continue its current high level of regulatory oversight and enforcement. Current levels of appropriations, if not reduced under a proposed sequestration reduction of 8.2% across-the-board ($320 million), which is unlikely, also provides the agency with necessary resources to implement the 5-year agenda contained in the recently enacted prescription drug user fee bill, the “Food and Drug Administration Safety and Innovation Act” (FDASIA). New FDA regulations, which were delayed or stalled before the election, will likely be published in proposed or final form, potentially provoking a Congressional response, along with the potential expansion of existing authorities including regulation of cigars, e-cigarettes, pipe tobacco and dissolvable tobacco products under the Tobacco Control Act.
- Food and Drug Law Institute
- Regulatory Affairs Professionals Society
- American Health Lawyers Association