Roses are Red, When Lawyers are Blue

Roses are Red, When Lawyers are Blue

John Haystead


e-mail: [email protected]

The FDA plans to release its long-anticipated revised GMP regulations in June. Although expected to provide some much-needed headway toward a common set of international standards and audit procedures, the new regulations will not provide a solution to the FDA`s, and therefore industry`s, biggest concern–FDA`s experienced-manpower shortage and audit-turnaround time. The question remains open as to who will actually verify compliance, as well as how many different inspections and certifications will continue to be necessary for firms wishing to do business internationally.

For years, the pharmaceutical and medical device industries have clamored for the adoption of third-party audits by the FDA, but as the inevitability of their approval looms larger, the third-party “rose” may be starting to lose some of its bloom. That`s because, as is always the case when bureaucracies and protection-from-lawsuits become the principle factors driving the implementation mechanism of a good idea, the promised benefits get overwhelmed by the price of paper.

It`s becoming increasingly clear that if/when the FDA approves third-party audits, there will be some hefty strings attached. For example, although ostensibly to protect itself from accusations of bias toward one certification firm or another, but more likely to protect itself from assuming legal responsibility, the FDA has already said it will not maintain a “list” of accredited vendors–yet, it will define the criteria for qualified certification firms, and it will audit results. In other words, manufacturers will not only be responsible for ensuring that their facilities and processes meet GMP, ISO etc., they will also be responsible for ensuring that the certification firms they use are up to snuff as well.

If past results are any indication of future performance, manufacturers can expect excruciatingly detailed audits and documentation requirements from their third-party vendors, whose businesses will depend on maintaining their credibility with the FDA. In fact, manufacturers may ultimately welcome such excessive (if pointless) scrutiny as long as it provides some comfort against the far greater legal liabilities associated with “contracting with an inept certification firm.”

Meanwhile, back at FDA headquarters, one can expect the folks that used to, themselves, conduct manufacturer audits to instead become extremely adept at pointing out how the third-party vendors are doing it all wrong, passing along their “advice” and “recommendations,” all of which, of course, will ultimately also become the responsibility of the manufacturers. It seems the implementation process may have just about turned this rose into potpourri already.

While it may be unfair to take such a cynical view so early in the process, then again, there`s no time like the present to nip a weed in the bud. One thing is for sure, the FDA can`t have it both ways. If they are going to allow third-party auditors, then they are going to have to stand behind them. As a minimum, the FDA must accept the responsibility for validating the credentials of all qualified inspectors, whether they are FDA employees, or third-party licensees. Otherwise, by whatever name you call it, this rose won`t smell at all sweet.


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