Ranbaxy Laboratories has been given a blueprint for removing regulatory constraints it incurred when it was discovered that some of its plants had severe manufacturing and data integrity issues. Now it must prove it can follow it.
The company has said it is pleased with the progress being made, but read the 55-page consent decree with the Justice Department, disclosed last week, and you see just how many hoops the Indian company must jump through. These include a requirement that it establish a whistleblower-like disclosure program for employees.
A big part of the decree--as pointed out by FiercePharma on Friday--is that the Indian company is giving up the first-to-file (FTF) exclusivity rights on three undisclosed generics. It has 8 pending applications, some obviously worth more than others, so the potential impact is yet unknown.
But as Ravi Ananthanarayanan points out in an article on livemint.com, for another four FTF drugs it has to comply with data submission and audit requirements by certain dates or lose exclusivity for those as well.
A review of the consent degree to which the blog Pharmalot links shows just how high the hoops are being held. It essentially requires the company to hire experts in data integrity and manufacturing who will watch over its shoulder, make recommendations, and, if they don't like the responses they get, take the issues up with the FDA.
Among other things, Ranbaxy must hire a completely independent and outside auditor to be a data integrity expert to work with the company and the FDA on internal audits. The data expert's purview can extend to auditing third-party suppliers and if any resist, the expert promptly notifies the FDA.
Ranbaxy has about four months to establish an Office of Data Reliability, staffed by the chief data reliability officer who shall report directly to the managing director of Ranbaxy and will have broad powers to make recommendations about applications and how employees are performing. Any recommendations made to the director must be reported to the FDA as well. Tight limits are put on all applications from Ranbaxy until this office is running.
The decree puts severe limits on a closed plant in Gloversville, N.Y., if it is reopened, along with plants in India. For its plants in Paonta Sahib and Dewas in India, it must hire an independent current good manufacturing practices expert who can report to the FDA independently if there are any disagreements with Ranbaxy over recommended improvements.
And in case anything slips by these controls, Ranbaxy must establish, and publicize, an anonymous disclosure program so employees can report to the data reliability office any "suspected violations."
As the livemint.com article points out, the fact that regulators approved Ranbaxy to sell generic Lipitor in the U.S. may be a sign of faith. Still, all of these stipulations take time and money. And violate the decree, or submit false data again, and the company faces tens of millions of dollars in fines.
- see the decree (.pdf)
- read the article on livemint.com
- here's the Pharmalot story
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