Compounded Drugs May Return To Supreme Court After 5th Circuit Backs FDAMA
The Supreme Court could once again be asked to consider FDA's authority over compounded drugs following an appeals court ruling that found the products are considered "new drugs" but are entitled to safe harbor protections under the FDA Modernization Act
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The meningitis outbreak caused by contaminated injectable steroids from a Massachusetts pharmacy is prompting lawmakers to pursue legislation that would clarify FDA’s authority over compounders. The challenge for FDA Commissioner Hamburg is convincing Congress to act, but not deliver an unfunded mandate. One thing is clear: it won’t be a quiet start to 2013 in biopharma legislation.
As meningitis outbreak widens, FDA and members of Congress are calling for clarification of what jurisdiction the agency has over pharmacies, but agency officials are stopping short of asking for clear new authorities.
Wyeth will probably be satisfied by FDA's response to its citizen petition appealing for regulatory action against pharmacies distributing compounded hormone replacement therapy products. Although the agency denied the bulk of Wyeth's petition, FDA took action against compounding pharmacies for several related violations