By Alexander Gaffney, RF News Editor
In remarks made on 30 September 2013 at the 2013 RAPS Regulatory Convergence conference, Howard Sklamberg, director of the Center for Drug Evaluation and Research's (CDER) Office of Compliance, provided a number of glimpses into what his office has in store over the coming months.
The Case for Quality (for Drugs, too)
The first should be of little surprise to anyone who has kept tabs on the US Food and Drug Administration (FDA) in recent years: Quality. As with its medical device center, the Center for Devices and Radiological Health (CDRH), FDA is seeking to make a similar "case for quality" within the pharmaceutical sector.
"CDER is focusing on ways of improving its assessment of quality," Sklamberg said. "We're in the process of forming an Office of Pharmaceutical Quality (OPQ)," which would combine many review functions--good manufacturing practices and chemistry, manufacturing and controls, for example--that are currently spread throughout various CDER offices into one office.
The goal, Skalmberg said, is to adopt a "lifecycle approach to reviewing products," much in the same way that regulators within industry often work.
From Lagging to Leading
Sklamberg also spoke at length about product surveillance, both for traditional and compounded pharmaceutical products. The key, he said, was to move away from traditionally lagging indicators and toward a better surveillance function.
He said current efforts within this space are focused on trying to find uniform metrics across the industry that could facilitate better overall compliance.
This also applied to various geographic regions, Sklamberg added. "We want to be able to see where the leading indicators are, regardless of where they are located."
But like most other divisions of FDA, a major focus of the Office of Compliance remains the Food and Drug Administration Safety and Innovation Act (FDASIA), he said. These activities vary widely, including reducing a backlog of applications, clearing new applications, ensuring the security of the supply chain, leveraging its new authorities in constructive ways and obtaining metrics from industry.
Struggles at Home and Abroad
The center has also been at the epicenter of a debate about whether the agency at large has sufficient authority to regulate pharmaceutical compounders. Sklamberg refused to comment on current efforts to alter FDA's enforcement paradigm by the House and Senate, but noted the legal difficulties the agency continues to face--various legal setbacks, a general lack of information, and a difficult time defining where a compounding pharmacy becomes a pharmaceutical manufacturer in practice.
