A panel of experts will advise FDA June 29 and 30 on whether to take certain types of over-the-counter acetaminophen products off the OTC market.
No one is on top of this issue and what it means for your business like "The Tan Sheet," as our exclusive profile of some of the panelists reveals. If FDA's regulation of OTC drugs affects your business, you need to read Elizabeth Crawford's story, Meet The NDAC, Minus One... provided for free below.
(On June 25, look for her piece on manufacturers' take on FDA's possible acetaminophen actions at "The Tan Sheet" here [$]).
Reporters Crawford and Christopher Walker will be at the meeting, so look for us there. We'll provide up-to-the-minute reporting and then break down what it means for your business in the future.
Enjoy this complimentary story, below. For an accompanying chart of the NDAC members, read the Tan Sheet here (subscribers only. But get a sub or a free trial here,). And for a look at the potential impact of the acetaminophen issues on the OTC industry,read this).
Meet The NDAC, Minus One, As Conflict Of Interest Rules Come Into Play
New Nonprescription Drugs Advisory Committee member James Kehrer's expertise on acetaminophen toxicity should make him a key figure at FDA's upcoming meeting on the drug, he says.
But when NDAC convenes with two other committees June 29-30 to discuss acetaminophen hepatotoxicity risks, Kehrer will be notably absent.
A professor and dean of the College of Pharmacy at Washington State University, Kehrer's case exemplifies concerns that FDA's conflict of interest policy could unduly restrict the pool of experts eligible for advisory committee posts.
FDA excluded Kehrer from the upcoming meeting because his investment in a health care mutual fund exceeds the $50,000 cap on combined financial conflicts.
Kehrer cannot influence the different stocks the fund owns, buys or sells, he says, and he has "never had research funding from the drug industry in my life."
"I am frankly very frustrated with the current conflict of interest guidelines," Kehrer said. "I would be required to take a financial hit to serve despite having absolutely no conflicts in terms of my work history, and the amount of my holdings are less than 1.5 percent of my net worth."
He is one of the few new NDAC members with a research background in acetaminophen toxicity (see chart: " 1 Nonprescription Drugs Advisory Committee Roster' following page: 'NDAC Roster ").
Critics say FDA's conflict of interest rules could fail to appropriately balance conflicts of interest and necessary expertise. Groups, including the American Society of Clinical Oncology, raised concerns about the policy.
When the guidance was proposed, the Grocery Manufacturers Association maintained that FDA's "one-size-fits-all approach" and decision to exclude members with financial holdings exceeding $50,000 despite a need for their expertise, "is more restrictive than necessary and could seriously undermine FDA's ability to recruit the most talented and knowledgeable scientific advisors."
The group noted FDA's old policy allowed the agency to weigh the need for the individual's expertise and the potential for conflict. The current policy is not as flexible.
FDA revised the conflict of interest standard to meet requirements of the FDA Amendments Act of 2007 and to "increase the transparency, clarity and consistency of the advisory committee process and enhance public trust," according to the guidance.
The agency can seek a waiver to allow potential committee members to serve if they have a conflict of interest, but a FDAAA provision caps the number of waivers FDA can grant annually and requires the agency to reduce waivers 5 percent annually until 2012.
FDA denied Kehrer a waiver to participate in the next NDAC meeting, he said.
In part because of the tighter conflict of interest policy and limited waivers, FDA struggles to fill its committee slots. It rounded up nine new NDAC members this spring, including Kehrer, but the agency's Web site indicates there are at least three vacancies on the committee.
Kehrer said he wanted to serve on the committee because he believes "it is a responsibility of those in academia to help assure safe medicines, and I believe my expertise is extensive and unbiased."
He said he would have been a strong addition to the committee at the upcoming acetaminophen meeting in part because he researched how dimethyl sulfoxide, a common element in which drugs are dissolved, protects against acetaminophen-induced hepatotoxicity. He also researched the effect of 1,3-bis(2-chloroethyl)-1-nitrosourea on acetaminophen-induced hepatotoxicity, and the hepatotoxic effects of a combination of acetaminophen and BCNU in mice.
Kehrer has a bachelor's degree in pharmacy from Purdue University and a doctorate in basic research in toxicology from the University of Iowa. He served 25 years on the faculty at the University of Texas at Austin College of Pharmacy and is an experienced former scientific advisory board member for the Environmental Protection Agency.
Kehrer added that he applied online to join the committee in part because he is interested in contributing to the discussion about potential Rx-to-OTC switches.
"There are some more out there that I think ... could also be converted and provide the American public readier access to some powerful drugs that are extremely safe," he said, adding that he would "want to hear the discussions" before voting on any particular switch.
New Expertise On NDAC
Other new NDAC members offer a wide range of expertise to contribute to the acetaminophen debate and other ongoing or potentially upcoming conversations about nonprescription products or switches.
The panel still will include at least one member with acetaminophen-specific backgrounds.
Currently the director of the Department of Medical Toxicology at Banner Good Samaritan Medical Center in Phoenix, new NDAC member Steve Curry researched false positive acetaminophen levels associated with hyperbilirubinemia, which is associated with liver disease. He also studied the efficacy of decontamination using acetaminophen in children as a marker.
With an expertise in medical toxicology and emergency medicine, he studied pseudoephedrine risks and the use of lovastatin as well.
Another new committee member - Neil Farber - is an internal medicine expert with an interest in patient-physician communication and medical ethics. He says he can offer the agency insight on how patients approach medications.
"We need to be sure that all drug manufacturers are sensitive to the fact that not all people are equally savvy in terms of medications," said Farber, the clinical medical director and a professor of medicine at the University of California, San Diego.
While Farber does not have specific OTC experience, he says he takes a "patient-centered approach to communication, meaning [I] interact with patients from their perspective, and I think that is a help in terms of understanding sort of what kinds of things patients might see and encounter when they deal with OTC medications."
He added drug makers "do a fairly good job" communicating with consumers, but they should assure the reading level of labels is appropriate, clear and easy to understand.
Consumers' ability to understand labels could be pivotal at the upcoming meeting when it comes to whether they can identify when acetaminophen is in combination products, what the doses are and the risks of overdose.
While technically a new NDAC committee member, Farber says he feels prepared and knows what to expect at the upcoming meeting because he served as a temporary voting member at the most recent NDAC meeting October 2008 about the creation of MedKits in response to a potential flu pandemic.
Leslie Walker-Harding, director of adolescent medicine at Seattle Children's Hospital, also participated as a temporary voting member at the MedKits meeting before becoming an official new member.
During that meeting, Walker-Harding's clinical and research interest in the development of community- involved academic adolescent medicine programs likely prompted her to suggest incorporating how to deal with and understand pandemic versus epidemic in health literacy or emergency preparedness education systems.
She also suggested multiple times at the meeting that flu drug manufacturers expand pediatric safety and efficacy tests and make labels comprehensible to children as young as 10 years.
Her demonstrated desire that manufacturers conduct pediatric drug studies could influence her view of other OTC drugs, including the much-debated safety and efficacy of pediatric cough and cold products, if the issue comes before NDAC again.
Walker-Harding also conducted research on adolescent health-risk behaviors, including smoking initiation and teenage pregnancy prevention.
Renee Jenkins, whose NDAC term begins immediately, shares Walker-Harding's interest in teenage pregnancy prevention.
Jenkins is a professor and chair of the Pediatrics and Child Health department at Howard University, chair of the pediatric section of the National Medical Association and was the first black president of the Society of Adolescent Medicine.
While serving as 2007-2008 president of the American Academy of Pediatrics, Jenkins spoke out against the use of pediatric OTC cough/cold products. She encouraged parents to use "safer" treatments such as saline nose drops and humidifiers to ease cough/cold symptoms.
She also urged FDA to study the safety and efficacy of pediatric cough/cold medicines for children older than 2 years and advised that labeling should state when studies show the products are ineffective in children under 6 years.
Pharmacist Group Presidents Join NDAC
Also joining NDAC are two former presidents of the American Pharmacists Association with track records supporting Rx-to-OTC switches and the creation of a behind-the-counter drug class.
Internationally recognized OTC drug expert Janet Engle and CVS pharmacist Winifred Landis may be new NDAC members, but they are not new to NDAC meetings.
Currently a professor and executive associate dean at the College of Pharmacy, University of Illinois at Chicago, Engle represented APhA at multiple NDAC meetings as either president or a board member.
At several NDAC meetings Engle advocated for Rx-to-OTC switches, including at switch meetings for Plan B , Claritin and Mevacor. In each case she noted that pharmacists are trained and available to help consumers appropriately select and use OTC drugs.
She often tempered her support for switches by stressing that product labeling must clearly articulate when OTC use is appropriate and direct consumers to ask their pharmacist when product use falls outside the label parameters.
She advocated the creation of a behind-the-counter class of drugs while testifying to NDAC during the 2005 Mevacor switch meeting.
Beyond switches, Engle studied the appropriate use of nonprescription analgesics in pediatric patients and testified on the legibility of analgesic warnings on OTC packages. She also contributed to APhA's Handbook of Nonprescription Drugs.
Landis echoed Engle's support for a BTC class and improved OTC product labels during her tenure as president of APhA.
She also weighed in on the ongoing debate about the availability of pediatric cough/cold products. In a statement before NDAC in October 2007, she said the absence of pediatric-specific cough/cold formulas and doses led APhA to support FDA's push for more extensive pediatric studies.
She spoke out against brand-name line extensions for OTC products containing different active ingredients because consumers may not understand which ingredients are in which products.
Potential consumer confusion about which ingredients are in combination products is a core issue at the upcoming acetaminophen NDAC meeting, at which committee members will discuss whether to remove the pain relief ingredient from combination products.
The committee also will discuss the option of making some acetaminophen products prescription- only and potentially introducing sales restrictions.
In this area, Walid Gellad, who joins NDAC for the first time, could contribute his expertise on pharmacoeconomics.
Gellad is an assistant professor of medicine at the Center for Health Equity Research and Promotion in Pittsburgh, and researches pharmacoeconomics, Medicare Part D and prescription drug costs, and medical access for seniors and veterans. Gellad also is an internal medicine and primary care expert.
The final new NDAC member, Dorraine Watts, is an associate professor at the Graduate School of Nursing Uniformed Services University of the Health Sciences in Bethesda, Md.
She offers expertise in nursing, statistics and research design, and has researched diagnosing blunt small bowel injuries and motor vehicle accidents.
- Elizabeth Crawford (e.crawford@elsevier.com)
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