Her message was very clear: Any company that has not crafted a systematic approach to compliance had better make this a priority, and soon.
Among the key points she mentioned was a new approach to Warning Letters, which will streamline the legal review process so that they can be issued more swiftly. After any problematic plant inspection, companies will have 15 days to respond before a warning letter is issued. She also mentioned a new "warning letter closeout" policy, that, in some cases, would notate on FDA's web site when followup inspections showed that companies and facilities had satisfied points brought up in a prior warning letter.
Dr. Hamburg also noted the need to integrate field and center activities and to listen to public concerns, and she affirmed a commitment to partnerships with sister Agencies abroad and within the U.S. She mentioned that she has already met with several EU counterparts to discuss confidential sharing of information that might help with enforcement.
The Commissioner recapped two success stories involving streamlined enforcement: FDA's swift response to websites selling fake H1N1 cures, which resulted in 65 warning letters, and slowed the growth of bogus sites from 10/day to 2 per week, and its actions against companies selling harmful body building supplements.
Of course, she was speaking mainly to media representatives and lawyers at this venue, but Dr. Hamburg also appears to be far more media-savvy than her predecessors, noting the need for better and more frequent communication with the public. "We need to publicize our actions and the rationale behind them," she said. She also quoted unnamed bloggers and trade press editors (how many FDA officials ever quote trade press?) who had described FDA's recent crackdown on H1N1 websites as "extraordinary" and "effective," suggesting a time in the future when such superlative terms would not be used when FDA is just doing is job.
Will voluntary programs become mandatory,or at least more fully explained?
In mentioning the clear need for a strong FDA, she also said that FDA would be also be responsible for clearly articulating and explaining requirements, to support compliance. More clarity in industry directives and guidances will be important, she said.
She said she was "impressed" by some companies clear commitment to compliance, and to the investments they had made to ensure compliance, implying that this will be necessary across the board.
No playing to the gallery
Dr. Hamburg did not take a confrontational tone to industry, nor did she play to the Washington gallery. Her outlook appears to presume that everyone involved is taking a strong risk management approach and focusing efforts on priorities. As she said during the question and answer session, "Enforcement is not an end in itself."
In responding to another question from the audience she described the need for clear timeframes for action. In some cases, she noted, "we've seen a lot of back and forth,and wait and see" with companies that have violated requirements. "We'll need to be as clear as possible about standards and expectations," she added.
That appears to apply to procedures within FDA as well. Although the Commissioner was very complimentary toward colleagues in the Agency, a key goal will be cutting through red tape. Being an "outsider" will aid these efforts. "Some of the time frames for some FDA enforcement efforts boggle the mind," she said. In a nod to long-time Agency insiders, she modestly stated "my own naivete may move things forward quickly." But, clearly, there's nothing naive about this Commissioner.
Note: I would have loved to ask about all the guidances that FDA has promoted over the past few years--like PAT,QbD and its draft validation guidance--and whether more explicit guidance and timelines will be set. That remains to be seen, although the question of whether PAT will become law generated some lively discussion (and a clash of egos) on the PAT and PhM/QbD groups on LinkedIn. If you're already members and are interested in PAT and QbD you might want to glance at them.