"Risk-based inspections will have a positive effect on FDA and generic-drug manufacturers," says DiLoreto. "In managing resources
most efficiently, FDA will be able to focus on those manufacturers having the most difficulty in implementing and maintaining
quality drug-production programs. Manufacturing facilities that have never been inspected will be considered high risk, and
manufacturers with a history of active successful quality programs will be considered to be lower risk," he explains.
Carla Vozone, business development director at Hovione and industry representative of the EFCG during the negotiation process
for the GDUFA, also points to the benefit of the GDUFA in "correcting the mismatch that existed in the inspection schedule
and the actual supply chain." Although approximately 80% of APIs for drugs marketed in the US come from India or China, inspections
of drug-manufacturing facilities in these countries are not proportional to these levels, explains Vozone. "Parity in inspections
is critical to ensure safety of generic medicines," she says. She also points to the value in the provisions of the GDUFA
that provide for a risk-adjusted surveillance inspections system to prioritize inspections of higher-risk facilities.
Also of significance is increased authority for FDA to deal with low-quality and counterfeit drugs. "Prior to the GDUFA, FDA
had little authority to prevent low-quality and counterfeit drugs from entering the supply chain," explains DiLoreto. As of
Oct. 1, 2012, FDA will have the authority to consider misbranded any drugs not produced in a registered and inspected manufacturing
facility. All drugs considered misbranded may be destroyed rather that returned so they will not be allowed to enter the supply
chain through different supply chain channels, he explains.
As the quality bar for generic drugs and APIs are raised under the GDUFA, the supply chain for generic drugs also may be affected,
notes Vozone. "Generic-drug manufacturers will have to do a risk assessment of their supply chains," she says. Issues, such
as increasing secondary sourcing or further evaluations of existing suppliers, will come into play. She also notes that the
amount of the user fees, which are still being determined, will oblige producers to evaluate their cost structures for supplying
a given generic API, and as a result, certain producers may exit the market for that product or the sector. These issues will
be important to take into consideration in the sourcing strategies for generic-drug manufacturers.
1. FDA, "Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Drug User Fee Cover Sheet;
Form FDA 3794," Federal Register
77 (144), 43844–43846 (2012).
2. FDA, Human Generic Drug Performance Goals and Procedures Fiscal Years 2013 through 2017 (Rockville, MD), July 7, 2012,
http://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM282505.pdf, accessed Aug. 15, 2012.
3. M. Hamburg, "Challenges and Opportunities for the Generic Drug Industry Remarks," presented at the GPhA Annual Meeting,
Orlando, FL, Feb. 23, 2012.