Ombudsman's Annual Report for 2007, FDA, Center for Drug Evaluation and Research (CDER)
Warren Rumble, CDER Ombudsman, retired this year from federal service. The new ombudsman for the Center is Virginia L. Behr. This report briefly explains the role of the CDER Ombudsman and details the number and variety of interactions between the Ombudsman’s Office and its constituents.
I. The Ombudsman’s Role
The United States Ombudsman’s Association (USOA) defines a governmental Ombudsman as “an independent, impartial public official with authority and responsibility to receive, investigate or informally address complaints about governmental actions, and, when appropriate, make findings and recommendations, and publish reports.”
The CDER Ombudsman primarily receives inquiries and investigates complaints from the regulated pharmaceutical industry (or the law firms representing them) and consumers and also provides general information on product development and regulation. If requested, the Ombudsman can informally resolve disputes or disseminate information about established appeals processes and other formal mechanisms for dispute resolution. The Ombudsman also receives comments from inside and outside the Center about the effectiveness of programs and about problems that impede CDER's performance of its mission. The Ombudsman makes recommendations for Center improvement to the Center Director but cannot require action or mandate change because ombudsmen do not have disciplinary or enforcement powers.
The CDER Ombudsman’s Office draws its ethical principles and standards from those established by the Coalition of Federal Ombudsmen, USOA, and the International Ombudsman Association. These include standards for ensuring confidentiality, neutrality, independence, a credible review process, and informality. The Office reports to the Director of the Office of Executive Programs within the Office of the Center Director. The Ombudsman is a member of the Coalition of Federal Ombudsmen.
II. Contact Methods, Demographics, and Most Common Topics
Consumers, law firms, and the pharmaceutical industry can contact the Ombudsman’s Office by fax, phone, postal mail, and electronic mail. Beginning in March, the Ombudsman’s Office instituted a different tracking system for phone calls and electronic mail; therefore, the phone and email data presented below reflect contacts and activities from March through December 2007 and the numbers for fax and regular mail encompass the full calendar year. In total, the Office received 660 communications, the vast majority (94%) of which came via electronic mail and phone. In many instances, several emails or phone calls were exchanged per case; those follow up correspondences were not counted for this report (i.e. the numbers below refer to initial contacts only).
Number of contacts and demographics
- Consumers and health care professionals = 37
- Pharmaceutical industry, law firms, consultants, and public or private research institutions = 147
- CDER employees = 58 (3 personnel problems, 55 general questions)
- Consumers and health care professionals = 223
- Pharmaceutical industry, law firms, consultants, and public or private research institutions = 148
- CDER employees = 7 personnel problems
- Fax – 2 (both were industry)
- Postal mail – 38
- Consumers and health care professionals = 7
- Pharmaceutical industry, law firms, consultants, and public or private research institutions = 31
Most Common Contact Topics from the Pharmaceutical Industry, Law Firms, Consultants, and Public or Private Research Institutions
- Regulatory jurisdiction
- Generic drug decisions (approvability) and taking too long to review applications
- Office of New Drugs (OND) review delays resulting in slowed drug development
- Unresponsiveness and communication delays
- Labeler code assignments and registration listing assignments taking too long
- Whistleblower reporting of unethical clinical research conduct including institutional review board issues and clinical study protocol violations
- Perceived unfair handling of an issue
- Lengthy response times to Citizen Petitions and Suitability Petitions
- Import/Export issues, usually detained products and seizures
- Enforcement actions taken on marketed drugs that do not have FDA approval
- Drug shortage problems
- Investigational New Drug Application (IND) and New Drug Application (NDA) requirements; review and application process questions
- IND termination
- Press enquiries
- Freedom of Information Act requests (response delay) and backlog
- New drug approval or nonapproval
- Clinical hold
- Particularly, delays in getting official correspondence from OND which explains the deficiencies (reasons for the hold)
- User Fee assessments and Orange Book listings
- Unlawful promotional activities by competitors
Most Common Contact Topics from Consumers and Health Care Professionals
- Reporting of drug adverse events and medication errors
- Voluntary withdrawal of Zelnorm, a drug to treat Irritable Bowel Syndrome, from the market.
- See the Zelnorm Information web page for more information
- Violative conduct by pharmaceutical companies (off-label promotion and violative manufacturing procedures)
- Drug costs and insurance problems
- Drug shortages
- Complaints from consumers about their doctors
- Personal importation of drugs not lawfully marketed in the United States
- The prevalence of unapproved marketed drugs, e.g. Lipodissolve injections proclaimed to “melt fat” and are not FDA approved
- Contaminated or adulterated drug suspected
- Study protocol violations as reported by study participants
- Pergolide availability for horses
- The drug pergolide was FDA approved for the treatment of the signs and symptoms of Parkinson’s in humans, but was removed from the market due to concerns about cardiac problems. Pergolide mesylate is commonly compounded from the bulk form and used “extralabel” as a treatment for Equine Pituitary Pars Intermedia Dysfunction (Equine Cushing’s Disease). Because of the market removal, horse owners asked FDA to figure out a way to make pergolide available to treat their horses.
- See the CVM Pergolide web page for more information
- Generic drug doesn’t seem to work the same as the brand drug
- Online pharmacy ‘spam’ email
- Oxycontin abuse and pleas to remove it from the market
- Misleading product websites
- Albuterol inhalers
- Because chlorofluorocarbons (CFCs) deplete the ozone layer, patients using CFC propelled albuterol metered dose inhalers are being switched to hydrofluoroalkanes (HFAs) propelled albuterol inhalers. The Ombudsman’s Office received several complaints that the HFA inhalers do not deliver the drug dose forcefully enough and get clogged up too easily. For more information, see Questions and Answers on Final Rule of Albuterol MDI's.
III. Product Jurisdiction for Combination and Single Entity Products
The CDER Ombudsman also serves as the Center’s Product Jurisdiction Officer. Many proposed products must be regulated by the FDA, but it is often not obvious which Center within FDA should take the lead for product review and regulation, particularly for combination products. The Product Jurisdiction Officer serves as CDER’s expert on establishing the regulatory identity of products as drugs, biologics, devices, or a combination of two or more (e.g. biologic and a device combined into one product), specifically to determine which FDA Center is most appropriate for reviewing each product. The Product Jurisdiction Officer responds to all Requests for Designation (RFD) from sponsors via the FDA Office of Combination Products (OCP) under 21 CFR Part 3.7 and to other informal requests for assignment of combination and single entity (noncombination) products.
This calendar year, the CDER Ombudsman’s Office responded to hundreds of informal jurisdiction questions from within and outside FDA and put forth CDER’s position on 44 RFDs (OCP received 77 RFDs, 24 of which were not filed. Of the 53 filed, OCP requested CDER consultation for 44 of them), most of which were drug/device combinations. More information about jurisdictional determinations can be found on the FDA Combination Products website.
IV. Outreach Effort
The CDER Ombudsman’s Office conducted outreach to explain the Ombudsman’s functions including product jurisdiction and dispute resolution at several venues; these included presentations to some of the CDER Offices, CDER International Regulators Forum, Regulatory Affairs Professional Society (Atlanta chapter), and the CDER New Reviewer’s Workshops. The Office also created an informative website for use by CDER employees.