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New FDA head aims for aggressive enforcement

Published on 11/08/09 at 12:29pm

The new head of US regulator the FDA has set out a vision to support public health, through tighter laws on medicines and a clampdown on any violation of those rules.

Commissioner Margaret Hamburg outlined her commitment "to prevent harm to the American people" through swift, aggressive, and effective enforcement of FDA regulations.

In a speech to industry representatives and consumers she said: "The FDA must be vigilant, the FDA must be strategic, the FDA must be quick, and the FDA must be visible. We must get the word out that the FDA is on the job."

Hamburg, a leading public health expert, was appointed by president Obama in March this year. The 54-year-old has considerable experience in public health and worked in the second term of Bill Clinton's administration.

She is joined by others at the organisation considered to be critics of pharma, and her latest announcement is in line with industry expectations for the regulator to toughen up. It also comes as Obama pushes for an overhaul of other aspects of the US healthcare system, to make it more cost effective and accessible to all.

Hamburg said that some FDA enforcement actions over the past several years "have been hampered by unreasonable delays" and "in some cases, serious violations have gone unaddressed for far too long". She added that the pathways for enforcement actions "can be too long and arduous when the public's health is in jeopardy".

First steps

Hamburg outlined six initial steps designed to hone the effectiveness and timeliness of the FDA's regulatory and enforcement system. They are:

* Set post-inspection deadlines: The FDA will establish a clear timeline for the industry to respond to significant FDA inspection findings, generally giving no more than 15 days to respond to such findings before the agency issues a warning letter or takes other enforcement action.

* Speed up the warning letter process: The FDA will streamline its warning letter process by limiting review of warning letters by the Office of Chief Counsel to those that present significant legal issues.

* Prioritise follow-up on warning letters and other enforcement actions: The FDA will work quickly to assess and follow up on corrective action taken by industry after a warning letter is issued or major product recall occurs.

* Work more closely with FDA's regulatory partners: In some cases - such as with food safety issues - state, local, and international officials can act more quickly than the FDA. When public health is at risk, the agency will coordinate with its regulatory partners to take rapid action.

* Be prepared to take immediate action in response to public health risks: To better protect the public health, the agency is prepared to act more quickly and aggressively to deal with significant public health concerns and violations. Such actions may occur before a formal warning letter is issued.

* Develop and implement a formal warning letter "close-out" process": If the agency can determine that a firm has fully corrected violations raised in a warning letter the agency will issue an official "close-out" notice and post this information on the FDA website. This will be an important motivator for corrective action by manufacturers.

Hamburg said by taking these steps the FDA would ensure that inspection results are taken seriously, that warning letters and enforcement actions occur in a timely manner and that steps are taken to protect consumers in cases where immediate enforcement action is not possible.

Drug development misconduct

A day after Hamburg outlined her vision for the FDA new efforts to prevent non-compliant investigators from participating in new drug development were announced.

These will see the regulator's debarment and disqualification procedures strengthened to better protect clinical trials participants and ensure product safety and effectiveness.

The FDA said compliance with its statutes and regulations is key to protecting clinical study participants and the general public.

In a statement it added: "The new debarment and disqualification procedures will also help ensure that sponsors of clinical studies do not unknowingly use individuals who potentially may be debarred or disqualified by the FDA."

Under current law, the FDA can ban individuals known to have broken the law from working for companies with approved or pending drug applications at the FDA. The agency can also disqualify researchers conducting clinical testing of new drugs and devices, if it decides they have not followed the rules. The regulator can also disqualify clinical investigators who have, for example, manipulated data so as to inaccurately report study findings.

"The FDA views any deviation from its high standards for developing or marketing drugs and devices as a potential threat to patient safety and public health," said Norris Alderson, the FDA's associate commissioner for science. "We will take strong action against anyone who chooses to ignore or flout the legal requirements for the products we regulate."

Congress recently criticised the regulator for not adequately using its debarment and disqualification powers, and, when they are used, being slow to remove people from the drug or device development process. The regulator subsequently revamped its debarment and disqualification procedures, leading to a considerable rise in their number and the speed at which they are carried out.

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