Regulatory Focus™ > News Articles > Hamburg Discusses Plan B Decision, Lawsuit Against Agency

Hamburg Discusses Plan B Decision, Lawsuit Against Agency

Posted 07 February 2012 | By

US Food and Drug Administration (FDA) Commissioner Margaret Hamburg gave a lengthy interview to Forum host Michael Krasney on a number of controversial topics during a 6 February interview, including a recent whistleblower lawsuit and the FDA's overruled decision regarding Plan B One-Step.

Hamburg discussed the controversial Plan B One-Step decision made last month by the agency. FDA had determined that the pill, used to prevent pregnancy by preventing ovulation or fertilization, was safe for persons under the age of 17 to purchase over the counter (OTC). The US Department of Health and Human Services Secretary Kathleen Sebelius overruled that decision, and required the company to submit more data in support of its application.

"The science supported the decision to move forward," said Hamburg. However, "the Secretary of Health and Human Services, to whom Congress has given the actual authority for decision-making in these matters […] determined that there wasn't sufficient data to support the younger ages," added Hamburg.

"We're waiting to hear back from the [sponsor] company to hear what steps they want to take next," said Hamburg.

Hamburg also addressed a lawsuit filed in early February by six FDA scientists. "There's a lot of misinformation that is out there and circulating," said Hamburg. "At FDA, we take very seriously the responsibility to protect commercial and confidential information, and at FDA we do follow established guidelines and a legal framework for protecting certain kinds of data from inappropriate use and inappropriate distribution."

FDA is currently being sued in the US District Court of Washington DC, for allegedly violating the privacy rights of six of its employees, who allege the agency monitored their communications to Congressional staff regarding their concerns that FDA was approving unsafe medical devices.

"FDA employees, when they sign on to their computers, are made aware about the possible monitoring of information. They don't have an assurance of privacy on certain types of communication," said Hamburg, who declined to discuss the specifics of the case.

Hamburg also took call-in questions, including one caller who pressed her on whether or not the agency "did more harm than good" when it denied, for instance, cancer patients access to potentially lifesaving drugs that had not yet been approved by the agency.

Hamburg responded, saying "there is a very importance balance between determining what products really work-what are safe and effective products, what products deliver a true benefit to patients in the near-term for individuals and also for patients in the next generation going forward-and making drugs available for individuals that have serious, life-threatening diseases without other options for treatment."

"Sometimes, unfortunately, for certain disease conditions and individuals, they might not have FDA-approved products available to them."

Speaking to a similar question several minutes later, Hamburg added, "it is important that these kinds of technologic devices and interventions really work as they're supposed to work [and] do what they're supposed to do."

"There have been issues with some of the products that have gone to market more quickly, turning out not to work as well as hoped," said Hamburg, adding that she "understands the frustration" of patients who think that the agency is moving too slowly.

Hamburg also highlighted FDA's wirk with other international regulatory agencies in order to get products to patients more quickly.

Hamburg also spoke to the user fee legislation currently going before Congress.  "We have worked very closely with representatives of the industry around these negotiations defining what are the critical issues, how can we strengthen programs, how can we address some of the concerns [discussed during the KQED interview], and how can we establish performance goals."

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