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Ombudsman’s Annual Report for 2006 The CDER Ombudsman’s office serves as a portal for consumers, regulated industry, and small business to access CDER to, among other things, comment on CDER programs and actions, get drug development and formal and informal dispute resolution information, obtain general information on drug regulation, and report adverse drug experiences. Industry, drug and device consultants contacted the office more often than consumers, and of those “industry” contacts, about a third related to jurisdictional and drug development assistance. As in previous years, several people contacted the office to report irregularities and possible fraud in conducting and reporting clinical trials, in manufacture’s promotional activities, and violations in pharmaceutical manufacturing. Several hundred people contacted the office to express their opinions urging the Agency to approve some drug therapies, and to disapprove or rescind the approval of other drug therapies. We had less hot topics in 2006 with consumers than in 2004 and 2005, but complaints about the unwanted e-mails from on-line pharmacies and direct-to-consumer advertising were certainly prominent. The most frequent complaint in 2006 was the implementation of the IPledge program administered by Covance Inc., a pharmaceutical services company. https://www.ipledgeprogram.com/ The intent of the program was to assure that no patient could receive a prescription for isotrentinoin without adequate safeguards that the patient was not pregnant. The Internet continues to be the consumer’s primary method of communication for contacting the office. We received many times more e-mails than telephone contacts on various issues. Numerous consumers requested assistance in reporting drug adverse events, and others commented on the high cost of medication, seizure of medications ordered from Canada, abuse of oxycodone, and the politicizing of FDA. The Ombudsman’s office handled the following types of cases and allegations:
The CDER Ombudsman serves as the Center’s jurisdiction officer. Many times it is not readily apparent where proposed products (especially combination products such as a drug with a device) will be reviewed and regulated within the Agency or in the Center. The intracenter jurisdictional issues are coordinated in the FDA’s Office of Combination Products (OCP). If a sponsor is not clear how and where a new product will be regulated, they may contact a Center jurisdiction officer or the OCP. The CDER Ombudsman’s office responded to hundreds of informal jurisdiction questions that helped guide product development. If the regulatory assignment is not readily apparent, the sponsor may submit to FDA a Request for Designation as defined in 21 CFR 3.7. The Agency received 76 of these requests in 2006. Most of these were combinations of drugs-devices. The Ombudsman’s office also is a contact for informal dispute resolution. In November 2004, the Center developed a pilot program “Documenting Differing Professional Opinions and Dispute Resolution” where CDER reviewers are provided a forum to discuss and resolve differing professional opinions at the Center Director level. www.fda.gov/cder/mapp/4151.2.pdf The Center did not review any reviewer disputes under this pilot program in 2005 or 2006, although there have been several public complaints by reviewers on topics such as the approval of the antibacterial drug Ketek (telithromycin) Tablets, and general drug safety review procedures. The Ombudsman’s office is also the contact for informal dispute resolution for sponsors and investigators regarding the procedural issues relating to the review of INDs and NDAs. The CDER Ombudsman’s office conducted outreach to explain the Ombudsman’s functions including product jurisdiction and dispute resolution at several venues including the Food and Drug Law Institute, the CDER New Drug review divisions, CDER International Forum, the CDER New Reviewer’s Workshops. The CDER Ombudsman’s office reports to the Director of the Center Director’s Office of Executive Programs. The Ombudsman is a member of the Coalition of Federal Ombudsmen and the American Association of Ombudsmen.
Date created: February 28, 2007 |
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