As of January 7, 2004, generic and brand drug firms entering into patent settlements must notify the Federal Trade Commission and the Department of Justice.
The notification requirement applies to deals involving the “manufacturing, marketing or sale” of products covered under ANDAs that are involved in a Paragraph IV challenge.Agreements must be filed within 10 days of execution, an FTC notice states.Generic firms that make deals with each other regarding 180-day exclusivity must also notify the antitrust agencies.
Agreement exempt from the reporting requirements include: purchase orders for raw materials; equipment and facility contracts; employment or consulting contracts; and packaging and labeling contracts.
Dispute Resolution Pilot To Cover Scientific And Technical Issues
An FDA dispute resolution pilot has recently been put into effect to cover scientific and technical Good Manufacturing Practices (GMP) but not procedural or administrative matters.The pilot covers “all disputes on scientific or technical issues related to cGMPs that arise as a result of cGMP and preapproval inspections (PAI) for manufacturers of veterinary and human drug products.”The pilot does not cover disputes over application commitment failures revealed through preapproval inspections. These issues are distinct from strictly GMP observations.Existing guidances must also be followed for resolving disputes that arise during all prelicense and preapproval inspections for human biological drugs since the pilot does not cover these areas of manufacturing.
The FDA is limiting the scope of the year-long pilot to domestic manufacturing facilities. Based on the experiences gained from the pilot, the FDA will decide whether or not to expand the scope of the final guidance to cover all facilities.
NCPA To Improve Drug Manufacturer Services
The National Community Pharmacists Association (NCPA) is developing additional services for its drug manufacturer members.NCPA currently has about 90 corporate members including drug manufacturers, wholesalers, technology firms and consumer product companies.
Th association hopes to increase its corporate membership by developing more service programs that would help manufacturers reach a larger number of pharmacies. Manufacturer messages could be targeted to help pharmacists identify people who have a condition for which they are not being treated or to help pharmacists promote drug therapy compliance. Both pharmacies and manufacturers would benefit from the effort to drive demand for appropriate drug therapies.
