Latest Drugwonks' Blog
I am delighted to inform you that, effective today, Kathleen (“Cook”) Uhl, M.D., will serve as acting director of the Office of Generic Drugs (OGD) while we initiate a nationwide search for a permanent director. Dr. Uhl most recently served as the senior advisor to the director for OGD.
Dr. Uhl brings a wealth of regulatory and medical policy, scientific, and management experience to the position. In her fifteen years with FDA, Dr. Uhl has become widely-regarded both inside and outside of the Agency as a compassionate, committed, and dedicated leader. Because of her strong management skills and extensive expertise in clinical pharmacology, I am confident in her abilities to lead OGD during a time of transition as we work to evolve quality throughout the Center and implement the Generic Drug User Fee Amendments of 2012.
Dr. Uhl began her FDA career in 1998 as a medical officer in what is now CDER’s Office of Clinical Pharmacology. She has served in numerous positions at FDA, including five years as the assistant commissioner for Women’s Health and as director of FDA’s Office of Women’s Health (OWH). Among her many accomplishments, she is credited with forging new relationships with other federal agencies and the scientific community by establishing a cross-Agency Women’s Health Advisory Council to more effectively identify, communicate, and act on key women’s health issues in the Agency -- and to more closely align OWH’s scientific program with Agency scientific initiatives.
Dr. Uhl returned to CDER in 2010 to serve as deputy director, Office of Medical Policy (OMP) -- a position she held until January of this year. She provided exemplary leadership to OMP during a time of extraordinary change and growth as OMP underwent a major organizational change by becoming a “Super office” -- an office that houses subordinate offices within its organizational structure. Dr. Uhl played a critical role in facilitating OMP’s significant growth in personnel and expanded scope of operations. Further, she was instrumental in FDA’s negotiations with industry for the authorization of the new Biosimilar User Fee Act of 2012 (BsUFA), which was enacted on July 9, 2012, as part of the Food and Drug Administration Safety and Innovation Act. Additionally, Dr. Uhl has extensive knowledge of current quality and risk management processes, as well as standards relevant to FDA’s laws and regulations.
Dr. Uhl received her medical degree from the Medical College of Pennsylvania and completed residency training in family medicine with subsequent fellowship training in medical research and clinical pharmacology. She has held a variety of leadership positions with the American Society of Clinical Pharmacology and Therapeutics (ASCPT), to include serving on their board of directors and as an associate editor for their journal. Further, in 2008 she received ASCPT’s distinguished service award for her outstanding efforts in advancing clinical pharmacology and therapeutics.
Before joining the Agency, she was a clinical investigator and clinician at Walter Reed Institute of Research and Walter Reed Army Medical Center. She retains faculty appointments as associate professor in family medicine and internal medicine at the Uniformed Services University and is a retired officer of the United States Public Health Service Commissioned Corps.
Please join me in welcoming Dr. Uhl to this position. We are fortunate to have someone with her expertise, experience, and abilities leading OGD at this critical juncture.
Janet Woodcock
Indeed, the cost of specialty drugs loom large on the horizon as the new driver of pharmaceutical costs (U.S. Drug Costs Dropped in 2012, but Rises Loom, NYT, March 19, 2013), but there are two issues absent from this article – and often from the larger debate, that are worth mentioning.
The first is that drug costs represent only 11.5% of our national healthcare expense (only 8.5% for on-patent “name brands.”) The second is that, as we make continued strides towards more and more accurate companion diagnostics, we will be able to grab the brass ring of the “four rights” (the right medicine in the right dose to the right patient at the right time). This is the real definition of “personalized medicine” and the ensuing reduction in therapeutic guesswork will save lives and the enormous expense of failing our way to clinical success.
BioCentury reports that in a speech to the Massachusetts Biotechnology Council on Friday, FDA Commissioner Margaret Hamburg provided an update on the status of two of the agency's regulatory initiatives -- the breakthrough drug and biosimilars pathways. Hamburg said the agency has received a total of 31 breakthrough therapy designation requests, nine of which have been granted and 10 denied. One request was withdrawn, and 11 are pending.
Breakthrough drug designation, which was created by the FDA Safety and Innovation Act, commits FDA to collaborate with a sponsor to enable expedited development and review of compounds for serious or life-threatening diseases that show substantial improvements over existing treatments in early trials. Hamburg said FDA is developing guidance to describe and explain the criteria for its expedited development and review programs, including breakthrough designation.
Additionally, Hamburg said the agency has not received any applications for a biosimilar or interchangeable biologic under the 351(k) pathway, which was signed into law in 2010 as part of the Affordable Care Act. As of March 14, Hamburg said the agency had received 51 requests for meetings for 12 different reference products, with 38 initial meetings held with potential sponsors. She said FDA has received 15 INDs for biosimilar development programs.
US Supreme Court is slated to hear oral arguments involving a case in which a patient sued the manufacturer of a generic version of the nonsteroidal anti-inflammatory drug, Clinoril (sulindac), alleging use of the NSAID caused her to become physically disfigured, disabled and almost completely bind. The blog said tomorrow's case could "likely settle lingering questions about a small but high-impact class of lawsuits against generics." Meanwhile, Democratic lawmakers "are at odds" with the Department of Justice, which is "siding with drug makers, arguing that the courts shouldn't be able to second-guess" the FDA's "approval decisions." In contrast, Rep. Henry Waxman (D-CA), who "wrote almost all" of the nation's generic drug laws, and Sen. Tom Harkin (D-IA) "disagree. ... Congress never intended for FDA approval to preempt lawsuits over drug safety, Waxman said in a court brief."
I believe you have my stapler.
So, what of the OPDP reorg?
The article below (from FDA Week) does a good job with the particulars. Let me add to (and slightly better position) my quotes therein.
One way to look at the problem is that OPDP is under-resourced in terms of dollars, staff – and staff expertise. True.
Another way to look at it is that the form and function of this Office needs to be reexamined. Also true.
And the answer isn’t user fees.
Sources Mixed On Impact Of FDA Drug Advertising Office Reorganization
The new structure of FDA's drug advertising compliance office -- a switch that divides up oversight by therapeutic area rather than by type of advertising -- could have mixed results, sources said following the agency's March 8 announcement of the reorganization. The more generalized approach could lead to less predictability for industry, but the change could also help focus reviewers, leading to greater efficiency and a more critical view of the data, sources said, noting the impact on enforcement actions is unclear.
Agency drug center chief Janet Woodcock said the changes will allow OPDP to more effectively review direct-to-consumer and health professional advertising by increasing efficiency, improving work distribution and eliminating redundancy, while also emphasizing the agency's commitment to providing close oversight of DTC advertising. The move comes as FDA vows to continue its tough scrutiny of off-label drug promotion despite a recent court decision that some have said could stem such oversight.
FDA announced March 8 that it is restructuring its two divisions overseeing consumer and professional drug advertising, and realigning them among various therapeutic divisions overseeing the two promotion categories.
Under the new structure, the new Division of Advertising and Promotion Review I will include four teams that will oversee consumer and professional advertising related to neurology and psychiatry; hematology; oncology; and analgesics, anesthetics and antivirals. Four teams in the new Division of Advertising and Promotion Review II will review promotion for osteoporosis, reproductive and urology; dental, dermatology, and metabolic and endocrine; allergy, gastroenterology, pulmonary and rheumatology; and anti-infective, cardiovascular, medical imaging, ophthalmology, renal and transplant.
Some sources contend the move is little more than "rearranging the furniture." Peter Pitts, president of the Center for Medicine in the Public Interest and a former associate commissioner for external relations at FDA, said the move shows OPDP is understaffed, adding that the move spreads existing resources too thin.
"It is simply taking an under-resourced office and relocating its existing expertise," he said.
Pitts said the move could have a downside as reviewers will need to become more generalized to oversee both consumer and professional advertising. A more generalized approach could mean less predictability, he said.
"What it will do is it will further decrease the predictability and advice that office offers," Pitts said. "That is certainly not a step in the right direction."
Arnie Friede, an attorney with his own practice, said in theory, the reorganization will allow reviewers to become experts on the science related to a certain class of drugs and reduce duplication, allowing more efficient reviews over time. He added that expertise could allow reviewers to view the data with a more critical eye. A better understanding of a class of drugs could make reviewers more sensitive to analysis that industry has done or it could lead them to be more skeptical, Friede said.
"I think that time will tell whether the rationale for the changes will accomplish those things," he said. "The rationale seems, in theory, reasonable. Whether that translates into more enforcement or less enforcement over time, that is hard to know."
The latest reorganization comes after FDA, in 2011, renamed and elevated OPDP within a new super office, creating separate divisions to examine consumer drug promotion and professional drug promotion. The most recent change was prompted by a review of the workload and review processes in OPDP's two divisions to improve their overall impact and effectiveness, according to Woodcock.
A review of generic medicine pricing in Europe
Generics and Biosimilars Initiative Journal (GaBI Journal). 2012;1(1):8-12.
“The penetration of generic medicines is more successful in countries that permit free pricing of medicines than in those that have price regulation. Although tendering systems may reduce (generic) medicine prices in the short term, little is known about the overall long-term impact of such systems.”
The rest of the story can be found here.
Also, see here for a related story in the Pink Sheet.
Michael Moore, are you listening?
CDER Staff:
I would like to make you aware of a change in the Office of Generic Drugs’ (OGD) leadership.
Dr. Greg Geba, OGD director, has informed me that he will resign from his position on March 15. With the pending realignment of OGD’s CMC functions into the new Office of Pharmaceutical Quality (OPQ), which Dr. Geba fully supports as part of the quality evolution in CDER, he nonetheless saw this movement as creating challenges for implementing his original and full vision for OGD’s remit. Additionally, it put into new perspective considerations for him relocating his family to the Washington, D.C. area.
Dr. Geba came to CDER during a busy time and has led OGD’s work to improve efficiencies in the generic drug review process — significantly reducing the backlog of pending ANDAs, preparing for the hiring of new staff, and successfully guiding OGD in implementing the Generic Drug User Fee Act (GDUFA), as well as overseeing OGD-related organizational changes to stand up the new OPQ.
Please join me in thanking Dr. Geba for his significant contributions and wishing him well.
In the interim, I will serve as the acting OGD director while we initiate a nationwide search for our next OGD director.
Janet Woodcock
Mayor Bloomberg 's controversial ban on large, sugary sodas fell flat Monday when a judge shredded nearly every legal argument advanced by the mayor’s lawyers and tossed the regulation out.
“Arbitrary and capricious” to be sure and, plainly speaking, trivial.
It’s important to put the situation, vis-à-vis sugar-sweetened beverages, into perspective.
Prohibition doesn’t work. How many times do we have to learn this lesson? What works is personal responsibility and adherence to the Aristotelian Mean (aka – moderation).
Sugar-sweetened beverages play a small and declining portion of the American diet – just 7 percent of total calories. By nearly every measure, the contribution of calories from beverages to the diet is declining. According to the CDC, added sugars consumed from soda is down 39 percent since 2000 and from 1999-2010, full-calorie soda sales have declined 12.5 percent. Yet obesity rates are still rising. We need to focus on real ideas that address the big picture.
It’s time to put tabloid headlines behind us and move on to addressing the real story.
In June the CDC reported that 20.5 percent of New York City high school students had no physical education classes -- compared with 14.4 percent a decade earlier.
New York City has not filed a physical education plan with the state since 1982. It’s time for Mayor Bloomberg to step down from the bully pulpit long enough to get our kids back into the gym.
It’s time for the Mayor to take a big gulp, stop talking about fizz and start focusing on phys ed.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
