Latest Drugwonks' Blog
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 One request was withdrawn, and 11 are pending.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.
Much brouhaha over the FDA’s Warning Letter to AMARC Enterprises.
The attention is due, in part, to pharma’s thirst for FDA guidance on the use of social media. Alas, while this particular FDA letter isn’t entirely ersatz, it isn’t entirely relevant to moving the agenda forward either. (Note: When asked about this letter, OPDP chief Tom Abrams passed the query along to CFSAN -- as dietary supplements are regulted as foods.) Nevertheless, there are some important lessons.
Here’s how the FDA letter begins:
This letter concerns your firm’s marketing of the products, Poly-MVA and Poly-MVA for Pets. The U.S. Food and Drug Administration (FDA) reviewed your websites, www.polymva.com and www.polymva.net, as well as literature included in the information packet which accompanied the sale and shipment of your product, “Poly MVA” on November 15 and has determined that “Poly MVA” is promoted for conditions that cause the product to be a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. The claims in the literature and on your websites establish that this product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of your product with these claims violates the Act.
Translation: You are promoting a dietary supplement as a drug.
No news there. The letter continues:
In addition, we reviewed your websites at www.polymva4pets.com and www.polymvaforpets.com where you promote and sell your “Poly-MVA for Pets” veterinary product. We have determined that Poly-MVA for Pets is intended for use in the cure, mitigation, treatment, or prevention of disease in animals, or to affect the structure or function of the body of animals, which makes it a drug under section 201(g)(1) of the Act. [21 U.S.C. § 321(g)(1)]. Further, as discussed below, this product is an unapproved new animal drug as defined by the Act and your marketing of it therefore violates the law.
Translation: You are marketing a dietary supplement as an animal drug.
Okay – so this is your garden-variety structure/function violation. But here’s where it get’s interesting.
The FDA isn’t just dinging AMARC on a blasé structure/function claim. The agency is calling them out because those claims are about curing cancer!
The point to be taken here is that the agency cannot (obviously) go after every dietary supplement company making inappropriate structure/function claims. The FDA needs to prioritize, to deliver the biggest bang for the regulatory buck. And false cancer claims are right up there at the top of the list.
It’s also important to note that, of the many promotional infractions, the issue of social media is at the bottom (literally) of the letter. This is not a letter about social media infractions, it’s a letter about promotional infractions of which social media is one dimension.
But what the FDA does write about social media is instructive:
We also note claims made on your Facebook account accessible at: https://www.facebook.com/poly.mva, which includes a link to your website at www.polymva.com. The following are examples of the claims:
In a March 10, 2011 post which was “liked” by “Poly Mva”:
- “PolyMVA has done wonders for me. I take it intravenously 2x a week and it has helped me tremendously. It enabled me to keep cancer at bay without the use of chemo and radiation…Thank you AMARC”
In a May 5, 2010 post you provide a link to the blog post titled, “Children with Cancer Often Use Alternative Approaches” which can be found on your website at www.polymva.com/blog-news/218/children-with-cancer-often-use-alternative-approaches. At the end of the post is the following statement and a link to the website, www.facr.org:
- “For information on how palladium lipoic complexes can nutritionally support the body during cancer and cancer therapy, visit the Foundation for Advancement in Cancer Research’s website.”
Folks – it’s not the platform that is non-compliant, it is the content. Why does everyone get weak-in-the-knees whenever the FDA mentions a contextual violation on social media? When the agency sends out warning letters on sales materials, do we jump up and down and say, “Jumpin' Jehosaphat, we can’t create sales materials!” (Or TV commercials. Or convention booth displays.)
Or websites.
Here’s what the FDA said about the AMARC website:
Examples of claims in the form of testimonials, on your websites, www.polymva.com and www.polymva.net, on the webpage titled, “Customer Experiences” include:
- “I want everyone to know that I am now 3 years clear of lung cancer!! When I was told I had a mass in my lung, the first thing I did when I returned home was to call AMARC Enterprises – the PolyMVA people. PolyMVA helped save my life. I began a regimen of PolyMVA…After 3 months, the Stage 2 cancer was down to Stage 1. And here I am, 3 years later…the PET Scan is as clear as a bell. Thank you again and again for the support that PolyMVA gave my body in my fight against cancer!”
- “...I said “No” Chemotherapy!...I became quite ill and was diagnosed with stage 3 ovarian cancer…I had surgery to remove a very large tumor and was scheduled to begin an aggressive chemotherapy regimen as the cancer had spread. Even with chemotherapy I was aware that the prognosis was not encouraging…One of the supplements that my naturopath highly recommended was Poly MVA…In my opinion anyone in my situation involving cancer could be greatly improved by using Poly MVA…”
It’s useful to look back at the FDA’s “most recent” missive on social media, the December 27, 2011 Draft Guidance, “Responding to Unsolicited Requests
For Off‐Label Information About Prescription Drugs and Medical Devices.”
Statements that promote a drug or medical device for uses other than those approved or cleared by FDA may be used as evidence of a new intended use.
Translation: It’s the content, not the platform.
Unsolicited requests are those initiated by persons or entities that are completely
independent of the relevant firm. (This may include many health care professionals, health care organizations, members of the academic community, and formulary committees, as well as consumers such as patients and caregivers). Requests that are prompted in any way by a manufacturer or its representatives are not unsolicited requests.
Translation: “Liking” an off-label post or sharing it under the guise of a “customer testimonial” (whether solicited or not) is off-label promotion.
The value of the AMARC letter isn’t to divine FDA intent across social media. The value is to remember that violative is violative across platforms.
In other words, if you wouldn’t say it off-line, don’t say it online.
Take a breath.
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.
