Having gotten the blessing of the Federal Trade Commission, a plan by generic drugmakers to share production information on critical drugs that are in short supply is close to launch.
The Generic Pharmaceutical Association (GPhA) says it is working with the FDA to tidy up details and select which drugs the program will initially gather information on.
The FTC, in a letter posted this week, says that although the information manufacturers will share could be misused to manipulate prices, the GPhA's plan has built-in sufficient safeguards to prevent that from happening. "Based on the information GPhA has provided, it appears that the proposed ARI program is not likely to harm competition," Markus H. Meier, assistant FTC director, says in the letter to the association's lawyers.
The GPhA last year conceived the Accelerated Recovery Initiative as a way to help the FDA deal with drug shortages. Many of the shortages involve generic drugs for which production was interrupted to fix poor manufacturing conditions at plants. Shortages of drugs jumped to 250 last year, from 56 in 2006.
The issue has the FDA searching for solutions and led a House committee to blame the FDA for the problem, suggesting that its plant inspections have been too aggressive. The FDA responded by saying that it was forced to act because some drugmakers were putting out products that could be dangerous to patients.
To help, the GPhA suggested its ARI program. It knew that if the FDA had information about which manufacturers produced certain drugs, how much they produced and future production plans, it would know to whom to turn in the case of a shortage. But drugmakers were worried about how the information could be collected without tripping over the obvious anti-trust implications of pooling the data.
The GPhA's solution was to enlist a third party that would gather the data, assess it and pass it along to the FDA, keeping both the association and drugmakers from having a hand in the collation of the data. Each company could voluntarily share its own information but would not have access to anyone else's. In April, the drug information expert IMS Health was named to fill that role. The plan is for IMS to use real-time supply and distribution information and combine it with market information it already collects. It will analyze the data and provide the FDA with information about how severe a shortage might be and possible routes to avoid or mitigate it.
"While this remains a complex issue that cannot be solved overnight, this type of private-public sector, multistakeholder collaboration is exactly what is required to respond to this crisis," Ralph G. Neas, GPhA's CEO, says in a release.
- here's the FTC letter
- read the GPhA release
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