The increase in generic drugs in the USA has had a conspicuous increase in recent years (only in 2012 almost 80% of prescriptions were sent to pharmacies with equivalent drugs). This prompted the American Congress - concerned about the safety and quality of generic drugs produced by foreign companies - to ask the General Inspection Office (OIG) to evaluate whether the Food and Drug Administration (FDA) was achieving parity of inspections for foreign and domestic producers (institutional task of the institution for verifying Good manufacturing practices [Gmp]).
The OIG analyzed FDA data relating to inspections of registered manufacturers of generic drugs in the period 2011-2013, verifying the implementation of pre-authorisation visits, the correctness of the registration process and interviewing the agency's staff on the efficiency of the inspection processes. The report found that the FDA increased its pre-approval inspections of 60% generic drug manufacturers between 2011 and 2013, without performing all the required checks.
In 2013, however, the FDA conducted surveillance actions against all generic manufacturers identified as high risk and progress was reported towards achieving parity of inspections of foreign and domestic manufacturers and in compliance with the registration of the drug by the manufacturer.
The OIG report, in the light of what has been verified, ends with 3 recommendations directed to the FDA: 1) intensify inspections, if appropriate, before approval, a method that could lead to more timely registration of these drugs, developing a time schedule to dispose of backlogs; 2) ensure that the mandatory request for authorization from the FDA is always made with a complete and updated database, sending warning letters to those who do not comply with these obligations; 3) use his authority to request records in lieu of or in advance of an audit, as document review completed early could save staff time during the onsite audit. The FDA agreed with all three recommendations.
Arturo Zenorini – Thursday, 04 June 2015 – Doctor33
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