Edward John Allera, co-chair of the firm’s FDA group, counsels clients on new product development and business opportunities in the areas of pharmaceuticals, hi-tech products, medical devices, food and cosmetics. Ed has devoted his entire career to health care, as both a pharmacist and an attorney.
He began his career at the Food and Drug Administration (FDA), where he served as associate chief counsel. Because of his ability to integrate science and the law, Ed has become highly-respected by clients in the pharma/biotech industry as the person to call in a “make-or-break” situation.
Clients rely on Ed for is his ability to combat overreaching FDA actions. He and the cadre of attorneys and scientists with whom he works are able to quickly generate sophisticated legal and scientific rebuttals to FDA actions. Ed and his team have also assisted clients in dealing with the Office of the Inspector General of the Department of Health and Human Services, the Department of Justice, Congress, Centers for Medicare and Medicaid Services (CMS) and numerous state officials.
Ed uses his keen historic and contemporary industry and business perspectives to assist clients in complete product life cycle management. Because he has a background in the science surrounding nearly all dosage forms and the dynamics of translational science, he has filed a large number of Citizen Petitions in the product life cycle management process.
On the compliance side, in an era when the FDA is taking a very hard line, Ed’s experience in dealing with most of FDA’s field districts, as well as officials at FDA headquarters, helps clients be successful within the complex maze of compliance and keep abreast of potentially damaging regulatory impacts to their business.
Because he is a former managing partner in the firm’s D.C. office, Ed has been able to orchestrate and build a coordinated team that seamlessly integrates members from other practice groups such as federal district court litigation, corporate finance & technology, intellectual property and most importantly, government relations & public policy.
What does Ed enjoy most about his role at Buchanan? The opportunity to work on new and creative scientific issues. “Our FDA/ Biotech team doesn’t work on the mundane. We get cutting edge projects,” Ed says. No doubt because of Ed’s contagious passion for the industry he supports, two of his four children have followed him into the healthcare related fields.
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