FDA, EMEA adopt orphan drug report system
ROCKVILLE, Md. Companies developing drugs to treat especially rare conditions may find winning regulatory approval in the United States and European Union a bit easier under a plan adopted by regulators on both sides of the Atlantic.
The Food and Drug Administration and its EU counterpart, the European Medicines Agency, announced Friday that they had adopted a single annual report system for orphan drugs, accepting the submission of a single annual report from sponsors of orphan drugs designated by the FDA and EMEA. The two agencies said it would allow regulators to better identify and share information throughout the development process.
Under current regulations, if a product receives orphan drug designation on the same day in the United States and European Union, sponsors must submit separate reports to each agency.
“This process provides benefits for both agencies,” FDA Office of Orphan Products Development director Timothy Cote said in a statement. “Additionally, it reduces the duplication involved for sponsors in reporting to two separate regulatory agencies.”
Report: Lawmakers seek to revise patent system
NEW YORK Lawmakers in Washington have taken steps to reform the U.S. patent system, according to published reports.
Reuters reported Thursday that Senate Judiciary Committee chairman Sen. Patrick Leahy, D-Vt., and other members Congress had reached an agreement on patent reform, introducing a bill that would allow the patent office to set its own fees and allow judges decide the importance of an infringed patent as part of a product.
Drug companies, which depend on small numbers of patents, have opposed the effort, while large computer and hardware companies have supported it, Reuters reported.
KV’s Ethex to plead guilty to criminal charges
ST. LOUIS The generic drug marketing and distribution division of KV Pharmaceuticals will plead guilty to criminal charges and close shop under a deal between KV and the Department of Justice, KV announced Thursday.
The generic drug maker said Ethex will plead guilty to two felony counts and pay $27.6 million to resolve a criminal investigation of the company that began amid allegations that it failed to file field alerts to inform regulators of manufacturing problems with the drugs dextroamphetamine and propafenone in 2008. The payment includes a fine, $2.3 million in restitution to the federal government and an administrative forfeiture of $1.8 million.
“This settlement marks an important milestone in our efforts to restore normalized business operations at KV, regain full regulatory and legal compliance and set KV on a new path moving forward,” KV interim CEO David Van Vliet said in a statement. “Management and the board have been working diligently to address this issue, and we are looking forward to having this matter resolved.”
Ethex recalled a large number of generic drugs in late 2008 and early 2009 due to problems such as possibly oversized tablets and manufacturing deficiencies. In March 2009, the Food and Drug Administration filed an injunction against KV to prevent it from making or distributing adulterated and unapproved drugs and forced it to destroy all the drugs it had recalled, forbidding it from resuming manufacturing until the FDA was satisfied that it had been brought back into compliance with regulations. KV said the current settlement would allow it to continue manufacturing once it had regained compliance with the FDA’s current good manufacturing practices regulations, also known as cGMP.