Latest Drugwonks' Blog
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.
During a Nevada Senate Judiciary Committee meeting on Wednesday, numerous physicians, alleging the prescription drug abuse measure (SB 75) would lead to a healthcare crisis, especially among the elderly, in the state, were joined in their opposition by drug manufacturers and industry groups, including the Chamber of Commerce. Even his Democratic colleagues found little in the measure to support during the first hearing on the proposed bill, which Committee Chair Tick Segerblom (D-Las Vegas) developed to make it easier for consumers to file suit against drug manufacturers and healthcare providers if patients becomes addicted to painkillers that were prescribed for them.
Who is Tick Segerblom? A lawyer. A lawyer who works on a contingency basis.
Just sayin’.
Nevada Senate Bill 75, if passed as written, it would make the manufacturer of a controlled substance criminally liability if a patient develops an addiction upon using that controlled substance. Prescribers are also on the line.
This bill provides that a person who suffers injuries as a result of an addiction to a prescription drug may bring a civil action against: (1) the manufacturer of the prescription drug; and (2) the provider of medical care who prescribed the prescription drug, if the provider of medical care knew or should have known of the person’s addiction to the prescription drug.
Patients would be able to recover both actual and punitive damages, without any limitation. The bill also has a provision that states that this liability is, “notwithstanding any other provision of law”. This means that, even if there were laws that would otherwise thwart the patient’s case, they won’t apply. The criminal laws that say one cannot illegally obtain and take prescription drugs - irrelevant. A law that bans a patient from “doctor shopping” – doesn’t matter. The fact that a manufacturer followed the law and disclosed all addictive information regarding a drug – immaterial.
The text of SB-75 bill can be found here.
The tort bar is watching -- and salivating.
And patient care is suffering.
FDA plans to implement during FY14-FY15 a new structured benefit-risk assessment framework to review new molecular entity (NME) NDAs and original BLAs, according to a five-year draft plan released by the agency. The new framework was one of FDA's commitments under PDUFA V. FDA said it plans to implement the framework when reviewing efficacy supplements for new/expanded indications by FY16, and for all NDAs by FY17. FDA said it will publish completed frameworks for newly approved products on its website.
PDUFA V is part of the FDA Safety and Innovation Act, which was enacted in June 2012 and took effect with the start of the fiscal year in October. The law's new set of rules on the review of applications to market NMEs provide for a longer, more interactive review process between FDA and sponsors.
The draft plan is worthwhile reading – but will it gather dust during sequestration?
“The fact that FDA did not require you to conduct a tQT for exenatide to support the safety of Bydureon did not relieve you of your obligation to submit those data once they became available.”
So wrote FDA’s John Jenkins (Director, CDER’s Office of New Drugs) in May of 2011.
FDA documents detailing its review of the diabetes drug Bydureon exenatide indicate the agency delayed approval by a year and a half after concluding the drug’s sponsor, Amylin Pharmaceuticals Inc., had intentionally and deceptively withheld data from a QT study that agency officials believed raised serious concerns about the product’s safety.
In fairness to Amylin, they have a different perspective on the situation. (A solid review of the story is in BioCentury and is worth a read.)
Many issues arise from this situation. One is clearly related to the current imbroglio over the call from Ben Goldacre, et al. for complete clinical trial transparency. A key take-away from the Amylin story is – you can run but you can’t hide. Or, perhaps more precisely, you can’t hide for long.
More importantly, the Amylin situation points out yet another reason why the FDA needs more funding – vigilance counts.
And costs.
Congressman John Conyers just introduced a bill that, if passed, would create government-run health care here in the United States. This same proposal for a "single-payer" system has been put forth in every Congress since 2003, and like all of those previous bills, Conyers’ legislation is destined to die an unceremonious death.
Almost simultaneously, Senator Richard Durbin (D-Ill.) and Rep. Jan Schakowsky (D-Ill.) introduced into the U.S. Senate and House of Representatives versions of a bill that would require the HHS secretary to negotiate Medicare Part D drug prices with pharmaceutical manufacturers. The Medicare Prescription Drug Savings and Choice Act of 2013 would offer one or more Medicare-administered prescription drug plans to compete with the privately administered prescription drug plans currently offered under Medicare Part D. Durbin and Schakowsky have introduced versions of the bill in Congress at least three times since Part D came into effect in 2006.
But just because such brazen attempts at socialized medicine are doomed to fail doesn’t mean the threat of government-run healthcare isn’t real. In fact, the current push to allow federal price controls in the Medicare drug benefit, Part D, is a first step towards a single-payer system.
While Medicare as a whole is a fiscal basket case -- due to run out of money in 2024 -- Part D has been the very model of a well functioning federal program since its implementation in 2006.
The Congressional Budget Office (CBO) found that, between 2004 and 2013, Part D will cost an extraordinary 45 percent below what was initially estimated. Premiums for the program, meanwhile, are roughly half of the government’s original projections. Part D enrollees pay, on average, $30 a month -- a rate that has remained essentially unchanged for years.
It’s no wonder that beneficiaries are so pleased with the program. In fact, 96 percent of those enrolled in Part D say that their coverage works well.
These unprecedented results are largely due to Part D’s market-based structure. Beneficiaries are free to choose from a slate of private drug coverage plans, forcing insurers to compete to offer the best options to American seniors. It’s hardly surprising that the program has led to low prices and satisfied customers.
Of course, anywhere there are market principles at work creating value for consumers, there are liberals eager to meddle -- and Part D is no exception. First, President Obama promised to dismantle Part D in the State of the Union with his proposal to “reduce taxpayer subsidies to prescription drug companies.” This was his coded way of saying that he intends to ruin one of the best market-based government programs in history.
And now, Minnesota Senator Amy Klobuchar has introduced a bill that makes good on the president’s promise. The legislation would allow the Department of Health and Human Services to negotiate directly with drug companies in order to set prices under Part D. The bill would repeal Part D's “non-interference clause” that was included in the law specifically to stop HHS from distorting the market by strong-arming drug companies.
It’s hard to see Klobuchar’s bill as anything but a federal power grab. Unhappy that a single-payer system is a political loser, the president and his fellow liberals are content to takeover the health sector one reform at a time. After all, despite the Democrats’ false promises of cost-savings, there’s no reason to revoke the non-interference clause.
Through their own negotiations with drugmakers, private insurance plans that operate under Part D have already had great success in keeping pharmaceutical prices down. In fact, the CBO has observed that Part D plans have “secured rebates somewhat larger than the average rebates observed in commercial health plans.”
What’s more, the CBO has said time and again that doing away with the non-interference clause “would have a negligible effect on federal spending.” In a report from 2009, they reiterated this view, explaining that such a reform would “have little, if any, effect on [drug] prices.”
In fact, allowing the feds to negotiate drug prices under Part D would likely have a negative effect on the program. The CBO predicts that, when HHS forces pharmaceutical firms to lower the cost of a particular drug, this tactic brings with it “the threat of not allowing that drug to be prescribed.”
In other words, Democrats want to take a program that provides affordable medicine for millions of seniors, and reform it in a way that limits drug access without saving money or addressing any of the systemic problems that afflict Medicare.
As Mr. Conyers’ bill demonstrates, Democrats will never succeed in creating a single-payer system by passing one, all-encompassing bill. Instead, liberals in Washington will have to take over the health sector bit by bit. The push to impose Part D price controls is the latest attempt to grab a little more power for the federal government. Those who support a healthcare system that benefits from choice and competition have a lot to be concerned about.
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.
