Regulatory

With you from the first step to the last. 

RMMS recognizes that regulatory matters are directly tied to our client’s business and commercialization goals, that’s why we partner with them through every stage of a product’s lifecycle to develop differentiated regulatory strategies, that align with their patent defenses and litigation strategies, to put our clients in the best position in competitive landscapes.

We work with agencies like we work with our clients. 

At the core of our practice is a nuance understanding of the Hatch-Waxman Amendments to the Food, Drug and Cosmetic Act (FDCA) and biosimilars, under the Public Health Service Act (PHSA) and Biologics Price Competition and Innovation Act (BPCIA). We regularly advise on expedited FDA review strategies for drugs and biological products, including matters related to the appropriate regulatory pathway, patent listing and certification issues, product labeling, agency review requirements, risk management programs, marketing exclusivities, and citizen petitions, just to name a few.

Through written submissions (both private controlled correspondence and the public citizen petition process) and meetings with agency personnel, our attorneys have successfully persuaded the FDA to, among other things:

• Retain a client’s 180-day exclusivity eligibility due to changes in the review requirements necessary to obtain approval 
• Accept labeling carve-out that allowed generic approval before expiration of the brand’s exclusivity and related patent 
• Deny Citizen Petitions designed to impose additional review requirements that would have delayed our client’s approval 
• Challenge another ANDA filer’s eligibility for 180-day exclusivity that allowed our client to get approval 
• Grant 3-year new clinical investigation exclusivity for our client’s product 
• Impose additional approval requirements to ensure safety of an emergency use combination drug-device product 

We have extensive experience challenging or defending agency decision-making in federal courts

RMMS attorneys have extensive experience facilitating market access through in suits filed under the Administrative Procedures Act both at the district court and appellate levels. We have been involved in a number of regulatory actions involving FDA/HHS aimed at delaying our clients’ approval and marketing based on unlawful claims of exclusivity, unnecessary labeling requirements, and dubious statutory arguments:

• Defending FDA’s interpretation of “biological product” and refusal to reclassify a complex generic product as a protein or an analogous product to be regulated under the PHSA 
• Defending FDA’s interpretation of the scope of orphan drug exclusivity in view of requirements to include pediatric information in drug labels 
• Defending 180-day exclusivity eligibility based on certain changes in the review requirements 
• Challenging FDA’s no forfeiture determination based on certain changes in the review requirements and failure to actively pursue approval 
• Challenging “court decision” trigger under the pre-MMA Hatch-Waxman framework 
• Defending FDA’s determination that an “authorized generic” can be sold during the first applicant’s 180-day exclusivity 
• Challenging FDA’s grant of multiple periods of 180-day exclusivity under the pre-MMA Hatch-Waxman framework