GPhA Third-Party Shortages Plan
Threatened by FTC’s Silence
Published May 23, 2012 in Generic Line
http://www.fdanews.com/newsletter/article/print?issueId=15803&articleId=146621
The FTC may not issue the advisory opinion GPhA is waiting for before launching its third-party drug shortage program, possibly derailing the initiative.
Because the GPhA plan involves sharing information among competitors — and possibly interfering with competitive practices — the FTC could squash the Accelerated Recovery Initiative (ARI). ARI is a plan to combat drug shortages by sharing certain manufacturing and product information with an independent third party. That third party would analyze the data and pass its results on to the FDA, which could use them to prevent shortages.
But the FTC may never issue an opinion on whether or not the plan passes anticompetitive muster, an FTC source told Generic Line. It only issues three or four advisory opinions a year, and the GPhA plan may not be one of them.
Because GPhA President Ralph Neas has maintained he won’t proceed with the ARI before receiving go-ahead from both HHS and the FTC, the FTC’s position casts uncertainty on the program’s future.
Neas previously expressed confidence the FTC would expedite its ARI decision because of the urgency of the drug-shortage situation (Generic Line, May 9). GPhA has already received FTC feedback, Neas noted
And the group is committed to its plan, Neas told Generic Line. “Should the FTC decline to offer an advisory opinion, we will reevaluate at that time and determine how best to continue the ARI in a manner that will satisfy any potential anti-trust concerns,” he said.
Neas had expressed hope ARI would be operational within three months.
The generics trade group already retooled its original proposal to better satisfy the FTC. Rather than funneling information from the third party back to manufacturers, the data would go to the FDA. GPhA member companies believed that proposal had a better chance of winning FTC approval.
The group has named IMS Health as its independent third-party (Generic Line, April 25).
Funneling information to a third party would allow a better flow of information, reducing shortages.
Meanwhile, the pending omnibus FDA user fee bill, which would authorize the Generic Drug User Fee Act, carries a section expressly to prevent drug shortages.
It would force manufacturers to give the FDA a six-month heads up of supply or manufacturing disruptions that could create shortages of drugs (See related story). — David Pittman
http://www.fdanews.com/newsletter/article/print?issueId=15803&articleId=146621
The FTC may not issue the advisory opinion GPhA is waiting for before launching its third-party drug shortage program, possibly derailing the initiative.
Because the GPhA plan involves sharing information among competitors — and possibly interfering with competitive practices — the FTC could squash the Accelerated Recovery Initiative (ARI). ARI is a plan to combat drug shortages by sharing certain manufacturing and product information with an independent third party. That third party would analyze the data and pass its results on to the FDA, which could use them to prevent shortages.
But the FTC may never issue an opinion on whether or not the plan passes anticompetitive muster, an FTC source told Generic Line. It only issues three or four advisory opinions a year, and the GPhA plan may not be one of them.
Because GPhA President Ralph Neas has maintained he won’t proceed with the ARI before receiving go-ahead from both HHS and the FTC, the FTC’s position casts uncertainty on the program’s future.
Neas previously expressed confidence the FTC would expedite its ARI decision because of the urgency of the drug-shortage situation (Generic Line, May 9). GPhA has already received FTC feedback, Neas noted
And the group is committed to its plan, Neas told Generic Line. “Should the FTC decline to offer an advisory opinion, we will reevaluate at that time and determine how best to continue the ARI in a manner that will satisfy any potential anti-trust concerns,” he said.
Neas had expressed hope ARI would be operational within three months.
The generics trade group already retooled its original proposal to better satisfy the FTC. Rather than funneling information from the third party back to manufacturers, the data would go to the FDA. GPhA member companies believed that proposal had a better chance of winning FTC approval.
The group has named IMS Health as its independent third-party (Generic Line, April 25).
Funneling information to a third party would allow a better flow of information, reducing shortages.
Meanwhile, the pending omnibus FDA user fee bill, which would authorize the Generic Drug User Fee Act, carries a section expressly to prevent drug shortages.
It would force manufacturers to give the FDA a six-month heads up of supply or manufacturing disruptions that could create shortages of drugs (See related story). — David Pittman