Biosimilar Battlefronts

10/01/2013 08:27 AM |

If you’re following the multifaceted and global debate over biosimilars, Steve Usdin’s article, Biosimilar battlefronts, is a must read. Authored by BioCentury's Steve Usdin, it’s opening paragraphs set the tone,

Biosimilars developers, manufacturers of originator biologics, payers and consumer groups are battling in state capitals, at FDA headquarters, and at the World Health Organization in Geneva over the rules that will shape perceptions and prescribing practices for copycat biologics in the U.S. and around the world.

Separately, none of the conflicts will have a decisive effect on either biosimilars developers or manufacturers of the products they hope to replace. But collectively, state laws on interchangeable biosimilar substitution, national and international naming practices, and FDA's labeling policies could have powerful effects on the market penetration of biosimilars.

The article covers many issues, both foreign and domestic – and one of the most important and most contentious is the issue of the nonproprietary names assigned to biosimilar and interchangeable biologics.

Usdin writes,

Proponents of distinctive non-proprietary names, including some of the biggest biotech companies, say patient safety and possibly the viability of whole classes of biologic drugs would be threatened by a failure to adopt their recommendations.

However, European regulators say distinct non-proprietary names are unnecessary, and some biosimilars companies argue such a naming scheme would put a dark cloud over biosimilar products that would substantially reduce sales.

A WHO group will meet on Oct. 22 to debate biosimilars naming principles.

The basic disagreement: one camp is arguing for biosimilars to keep the same international non-proprietary name (INN) as the reference product; a second camp argues for distinct INNs.

Supporters of distinct INNs say the ability of regulators to track and trace biologic drugs is essential for patient safety and the commercial viability of biologics — original and biosimilar. Opponents of distinct INNs say they are intended to confuse and scare physicians, patients and payers by drawing unnecessary distinctions between original biologics and biosimilars.

According to Geoffrey Eich, executive director of R&D policy at Amgen, “It seems counterintuitive, like sticking your head in the sand, to not want to include a distinguishing feature that allows us to aggregate info when appropriate and disaggregate when appropriate.”

Amgen supports the use of the reference product’s root INN, with the addition of a unique suffix or prefix for each biosimilar. “We believe having some kind of a distinguishable feature is absolutely essential to patient welfare, for pharmacovigilance,” Amgen’s Eich told BioCentury.

A WHO working group will meet Oct. 22-24 to discuss the creation of voluntary international standards for non-proprietary names for biosimilars.

WHO isn’t likely to adopt a final naming policy at the October meeting. Whatever policy it eventually adopts will not be binding, but it is likely to be adopted by developing countries, and, if it includes a distinctive naming system, could intensify pressure on European countries to adopt new naming policies.

Without casting any aspersions, “quality” and “pharmacovigilance” in developing countries takes on an entirely different meaning than similar concepts in more developed regulatory regimes.

At a meeting in Pretoria last week Tomas Salmonson, Chair of the EMA’s Committee for Medicinal Products for Human Use (CHMP), said that the working group is “split down the middle” on the issue of naming.

Stay tuned.

We do what we must, and call it by the best names. -- Ralph Waldo Emerson

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The House of Burgess

09/30/2013 07:31 AM |

BioCentury This Week is must see TV – especially if you work in the FDA’s government affairs office.

On this weekend’s program Representative Dr. Mike Burgess (R, TX) said that the OMB misinterpreted the law – and that user fees shouldn't have been sequestered.  

Dr. Burgess’ comments can be found here.

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CMPI Pain Event - Part 3

09/27/2013 10:57 PM |

The Keynote Speaker at CMPI’s September 10^th Capitol Hill Pain conference was Dr. Charles Inturrisi.
 
Dr. Charles Inturrisi is Professor of Pharmacology at Weill Cornell Medical College. He also has appointments in the Neuroscience Program at WCMC and with the Pain and Palliative Care Service, of the Memorial Sloan-Kettering Cancer Center and with the Drug Abuse Center at The Rockefeller University.
 
Dr. Inturrisi's current research is measuring the long term outcomes of treatments for chronic cancer and noncancer pain received by patients at four hospital-based outpatient Pain Clinics. He continues to have an interest the role of glutamate receptors in injury-induced pain and opioid tolerance, dependence and addictive behaviors. His research is directed at the discovery of new treatments for pain and drug addiction.
 
Dr. Inturrisi has received the John J. Bonica award of the Eastern Pain Association, a Distinguished Alumnus award from the University of Connecticut and the Excellence in Mentoring Award, Weill Cornell Medical College Postdoctoral Association. In 2008, Dr. Inturrisi received the first Graduate Dean’s Award for Excellence in Teaching and Mentoring of Graduate Students, presented by the Weill Cornell Graduate School of Medical Sciences.
 
He served as the president of the American Pain Society from 2008 to 2010 and in 2013 received the Distinguished Service Award from APS.
 
He was a member of the Institute of Medicine Committee that prepared the 2011 Report entitled “Relieving Pain in America”.
 
You can listen to Dr. Inturrisi’s presentation here (at the 1:03 mark) and the panel discussion that followed here.



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CMPI Pain Event - Part 2

09/27/2013 12:04 AM |

The second panel of CMPI’s September 10^th Capitol Hill Pain conference featured syndicated columnist Judy Foreman and BioCentury’s Steve Usdin.
 
Judy Foreman is a nationally syndicated health columnist whose “Health Sense” columns have appeared regularly in the Boston Globe, Los Angeles Times, Dallas Morning News and other national and international outlets. For years, she also wrote the Globe’s popular short feature, “Health Answers.”
 
She graduated Phi Beta Kappa from Wellesley College, served in the Peace Corps in Brazil for three years, then got a Master’s degree from the Harvard Graduate School of Education. From 2001 to 2004, she was a Lecturer on Medicine at Harvard Medical School and, for most of this time, was a scholar at the Brandeis Women’s Research Center. She has also been the host of a weekly, call-in radio show on Healthtalk.com and has won more than 50 journalism awards.
 
Her book on chronic pain, “A Nation in Pain – Healing Our Biggest Health Problem,” is due out in January, 2014 from Oxford University Press.
 
Steve Usdin has been Washington Editor of BioCentury since 1993, and has spent the past 20 years in the nation's capital covering political and policy issues affecting the life sciences sector. He also is the host of BioCentury This Week, BioCentury's weekly public affairs television program, as well as BioCentury Senior Editor responsible for coverage of social issues involving biotechnology. Steve’s reporting about biotechnology and biomedical policy has been cited in The Economist, The Wall Street Journal, the Washington Post, New Scientist and other publications. In 2012, the FDA Alumni Association named Steve the Harvey W. Wiley Lecturer, making him the first journalist to receive the Wiley Award. His book, “Engineering Communism: How Two Americans Spied for Stalin and Founded the Soviet Silicon Valley,” was published in 2005 by Yale University Press.
 
You can listen to Judy Foreman’s presentation and the panel discussion moderated by Peter Pitts here.



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India's Protectionist Prescription

09/25/2013 06:41 AM |

From today's edition of The Washington TImes.

India's Protectionist Prescription

At the recent Group of 20 Summit, Indian Prime Minister Manmohan Singh implored American policymakers to recommit to encouraging robust growth in India and other emerging markets. It was a surprising request from a leader who has spent the past year overseeing a barrage of damaging reforms that threaten the American economy — and India’s prosperity.

India has been systematically shutting out foreign goods in an effort to prop up domestic industries. Indian officials have recklessly ignored basic intellectual-property protections, unfairly bolstering their own businesses at the expense of improved public health. America’s leaders need to make clear that a fair and open relationship benefits both India and the United States. If India wants to remain a valued economic partner, this kind of crude protectionism won’t be tolerated.

In recent months, India’s policymakers have pulled out all the stops to give homegrown companies an unfair advantage. Since the beginning of last year, the government has raised customs duties on high-end cars from 75 percent to 100 percent. In April, leaders mandated that all cosmetic products be registered with the Indian government prior to marketing there — a bureaucratic hurdle designed to obstruct foreign firms. Yet another new regulation requires that procurements by the country’s military give priority to Indian defense firms.

All together, the country has enacted 33 potentially trade-restricting measures since October 2008, according to a recent report from the European Commission. Where India’s self-serving policies have been especially irresponsible, however, is in the area of intellectual property, particularly for cutting-edge pharmaceuticals.

The country’s blatant disregard for intellectual-property rights was made clear in April, when India’s Supreme Court denied patent protection for a new form of the cancer drug Gleevec. In doing so, the court gave India’s $22 billion domestic drug industry free rein to sell copycat versions of the treatment. Indian officials were quick to declare the decision a victory for their poorest citizens, applauding the court for helping to make sophisticated medicines more affordable.

This claim, however, entirely misrepresents the decision and its consequences. Officials strategically neglected to mention that 95 percent of Indians who rely on Gleevec already receive the drug free of charge, thanks to a program supported by the drug’s manufacturer, Novartis. The Gleevec case was never about improving pharmaceutical access; the real intent was always to benefit India’s drug manufacturers.

By unfairly boosting the country’s generic industry, the court announced to health care research firms around the world that India is no friend to cutting-edge treatments — and the repercussions of such a message could be severe.

A breakthrough drug such as Gleevec requires, on average, more than a decade of trial and error to create and costs firms more than $1 billion. If India isn’t willing to protect the basic intellectual-property protections companies need to earn back some of that investment, drug firms won’t be able to offer their products to Indian patients, much less give them away for free. Considering India is home to the largest population of people who lack access to essential drugs, Indian leaders can ill afford to shun foreign pharmaceutical companies and the advanced medicines they offer.

Additionally, there is the direct threat India’s policies pose to the American economy. U.S. exports to India totaled $33 billion in 2011, an increase of more than 12 percent from the year before. As Rep. John B. Larson, Connecticut Democrat, and Rep. Erik Paulsen, Minnesota Republican, noted in a recent letter to fellow lawmakers in Congress, no fewer than 75 U.S. industries depend on intellectual-property protections. All told, companies in these fields are responsible for roughly 40 million American jobs.

America’s technology, agriculture and information-technology industries — among other sectors — are already feeling the effects of India’s current policies. If India continues to erect trade barriers, more and more U.S. firms will be denied a valuable and growing market for their goods.

What’s more, if our leaders don’t reverse this protectionist shift, many other nations may follow suit. In fact, many already have: The European Commission found that between May 2012 and May 2013, 154 new trade-restricting measures were adopted around the world, while only 18 were lifted.

As Mr. Singh made clear at the G-20 summit, America continues to have considerable influence on India’s economic future. It’s time our leaders use this clout to pressure India’s government to abandon their destructive trade policies. Officials in Washington must demonstrate to India — and the world — that fair economic partnerships are mutually beneficial and that protectionist tactics won’t be tolerated.

Peter J. Pitts, a former associate commissioner at the Food and Drug Administration, is president of the Center for Medicine in the Public Interest.

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INNs and Outs.

09/24/2013 05:45 PM |

Dear Peter:

Another biologics nomenclature Citizen Petition was filed before this (see www.biopharmacopeia.com).   The GPhA petition concerns the issue of established/official nonproprietary names (useable for marketing and prescription filling), particularly, whether these should be unique or not (generic).  The earlier petition was filed in June by the Biotechnology Information Institute (R. Rader).  It requests FDA assign both unofficial unique and biosimilar/(bio)generic-like (or class) names (and/or other identifiers) upon biologics approvals,  along with public disclosures of needed basic agent/product descriptive information, including regarding supplemental approvals (product drift).  These names (and the nomenclature system) need to be coherent science/entity/product-based, i.e., totally new and with no connection or carry-over from INN/USAN, which as a legacy pre-recombinant nomenclature system is simply not workable with modern biologics.

Thank you.


Ronald A. Rader
President 
Biotechnology Information Institute
 

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CMPI Pain event

09/24/2013 03:29 AM |

On September 10^th CMPI hosted a conference on Capitol Hill in Washington, DC titled “Personalized Medicine and Responsible Access to Pain Medication.”
 
CMPI president Peter Pitts’ opening remarks at the conference can be found here.
 
In the next audio clips, Steve Usdin of BioCentury moderates a panel discussion addressing the role of patients and manufacturers as it concerns access to pain medications.
 
The panelists are listed below:
 
Cindy Steinberg, National Director of Policy and Advocacy, US Pain Foundation
Bob Twillman, Director of Policy and Advocacy, American Academy of Pain Management
Stuart Kim, Associate General Counsel, Regulatory Affairs, Mallinckrodt Pharmaceuticals
 
You can listen to Cindy Steinberg’s presentation and the panel discussion moderated by Steve Usdin here.
 


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Passing the Rupee

09/23/2013 07:19 AM |

In an interview with in-PharmaTechnologist.com, India’s Deputy Drug Controller, S. Eshwar Reddy, said some pretty honest – and frightening things about his nation’s perspective on global good manufacturing practices (GMP) – or purposeful lack thereof.

When asked if Indian manufacturers -- which produce more than 40 per cent of the API used in the US and Europe -- should be more sympathetic with Western guidelines and regulations, Reddy said the opposite should be true.

He said any additional requirements made are the sole responsibility of the authority which issues them.

“If the importing country has specific GMP requirements, that is their responsibility to audit the facilities. It is the responsibility of the importing country not the exporting country.”

Talk about passing the rupee.

“Being the Indian drug regulatory authority we don’t have any monitoring mechanism of other countries’ regulations. Each country has their own set of laws so Indian regulatory authorities don’t have any control.

So much for global regulatory fraternity.

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No Room at the INN

09/20/2013 10:51 AM |

BioCentury reports that the Generic Pharmaceutical Association has requested (via Citizen's Petition) that the FDA allow biosimilar and interchangeable biologics to use the same international non-proprietary name (INN) as reference biologics. GPhA said requiring different INNs for biosimilars and the original biologic would "inaccurately suggest that these products have meaningful clinical differences for patients."

The petition asserts that FDA lacks legal authority to require separate INNs for biosimilars. GPhA also noted that FDA has allowed originator biologics, including antihemophilic factors, to share an INN even if they differ in manufacturing method.

The agency is developing a guidance document on naming biosimilars and interchangeable biologics. According to Rachel Sherman, CDER’s Director of the Office of Medical, the naming policy will be designed to ensure that products can be tracked and traced, "Pharmacovigilance is our prime concern; we need to know who is getting what." noted Sherman.

Smart money (and savvy public health practice) predicts the petition will be denied.

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The Other Dr. J

09/19/2013 09:17 AM |

Last night I attended an elegant dinner at the New York Public Library (sponsored by Johnson & Johnson and Scientific American) where the 2013 Dr. Paul Janssen Award for Biomedical Research was presented to Dr. David Julius.

Dr. Julius received the award for his role in identifying the molecular mechanisms of touch, pain, and thermosensation. A scientific slam-dunk.

The highlight of the evening wasn’t the chicken and rice pilaf – it was Dr. Julius’ speech where he highlighted the inherent tension (“not conflict”) between the translational research and “curiosity-based science.”

A bold topic in a room filled with J&J’s top brass.

And an important topic for a number of reasons, not the least of which is the steady decrease on NIH funding for academia (a trend likely to continue unless they strike oil in Bethesda) and the nascent uptick in the outsourcing of pharma R&D to ivy-covered halls.

Per Dr. J, academe and industry and Uncle Sam are going to have to find new ways not only to mutually co-exist – but also to fruitfully collaborate.

At the end of the day it’s all about encouraging innovation, both incremental and discontinuous.

(I asked Dr. Julius to send me his remarks, and when they arrive I will be sure to post them.)

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Arms and the Man

09/19/2013 07:57 AM |

During a visit to a facility of leading Indian drugmaker Ranbaxy Laboratories Ltd last year, U.S. inspectors found that a black fiber embedded in a tablet may have been a hair from an employee's arm, according to documents seen by Reuters.  Read More & Comment...

A Decade of D

09/18/2013 09:45 AM |

On a wet and cold December 8, 2003, I sat in Constitution Hall and watched President Bush sign Part D into law. I helped (in my own small way) to make it happen. It’s something of which I’m proud.

Nearly a decade later that pride is stronger than ever. A new, nationally representative survey shows that an overwhelming nine out of 10 seniors with Medicare prescription drug coverage are satisfied.

·      Ninety-seven percent report that their coverage works well, and nearly three out of four seniors say it works “very well.”

Some specifics:

Part D Reliability at Its Highest Level: Those feeling “peace of mind” by having Part D coverage reached an all-time high level of 96 percent this year, with 73 percent saying they feel a “great deal” of peace of mind and 23 percent saying they feel “some” peace of mind.

Multiple Factors Drive High Satisfaction: Of those surveyed, 95 percent say their plan is convenient to use (a six percent increase from 2006), 84 percent say both their premiums and copays are affordable, and 88 percent say that their Part D plan is meeting their expectations.

Seniors Know What to Look for in a Part D Plan: Seniors believe that a variety of factors are important when deciding on a Part D plan. Eighty-eight percent think that the co-pays or coinsurance amounts are important, 86 percent believe that identifying the pharmacies where they could use their benefit to purchase their medicines is important, and 81 percent believe that the quality ratings of the plan are important to examine.

High Satisfaction Seen across Major Demographic Groups: High satisfaction levels within African American (95 percent) and Hispanic (94 percent) constituencies, as well as within various income levels (93 percent for both those earning less than $15,000 per year or more than $50,000 per year), reinforce the overall findings of a successful program. Additionally, 92 percent of men and 89 percent of women are satisfied with their coverage.

Seniors Rely on the Program: This year, 72 percent of beneficiaries said that they’re better off now than before they had Part D coverage – a four percent increase from last year. Eighty-six percent of seniors fear that eliminating Part D would increase their out-of-pocket prescription costs, and without a plan, 62 percent say they would be forced to cut back or eliminate some prescription regimens – a nine percent increase from 2012.

Seniors Would Recommend Coverage to Others: 89 percent of Part D enrollees say they would recommend the program to someone considering Medicare enrollment.

The full survey can be found here.

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Continued Quality Quandary

09/17/2013 09:26 AM |

Per the FDA’s import alert for drugs made in Ranbaxy's Mohali plant in northern India, the agency said it found "significant" violations of manufacturing rules, "including failure to adequately investigate manufacturing problems."

Now at least three of Ranbaxy's eight plants in India are unable to export to the U.S. Among its facilities outside of India, the Gloversville, N.Y., plant received a warning letter from the FDA in December 2009 for manufacturing violations. That facility has since been closed.

For more on this issue, see Indians and Cowboys.

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Indians and Cowboys

09/16/2013 10:29 AM |

Yes, Virginia. Quality counts.

Ranbaxy, the Indian generics manufacturer that recently paid half a billion dollars to settle fraud allegations and quality problems, has just received an FDA import alert against their production facility in Mohali, Punjab state.

The plant was set to make generic versions of blood-pressure pill Diovan.

Ranbaxy facilities in Dewas and Paonta Sahib, India, have both been on the FDA’s import alert list since 2009.

The relevance for more complicated products (like Gleevec) and biosimilars more broadly – is obvious.

According to Bloomberg report, the latest FDA notice “is a surprise,” said Prakash Agarwal, a health-care analyst with CIMB Securities India Pvt. Ltd. “The understanding was that, given the past experience with the two other facilities, the management would be on their toes to resolve these issues.”

Fast and loose is not an option.
 

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My name is Friday. I'm a cop.

09/13/2013 09:16 AM |

TGIF. Now let’s talk about Prescription Drug Monitoring Programs (PDMP) and the intended and unintended consequences thereof.

How wide a net should PDMPs cast before they begin to have the unintended consequence of restricting legitimate patient access? Well, according the general consensus at Tuesday’s Capital Hill conference on Personalized Medicine and Responsible Access to Pain Medication, PDMPs should include Schedules 2-4. To infinity and beyond may make for good soundbites, but makes no practical sense.

What about e-standards for inter-operability with electronic health records? This point was made by Bob Twillman, of the American Academy of Pain Management. Big Data is certainly part of the answer. Knowledge is Power.

And speaking of data – what about data entry? PDMPs should allow not only pharmacists, but also physicians and their staffs to be able to enter and update electronic records. Let’s get real – this is already the reality on the ground. But this must also be matched with proper oversight for both quality control and appropriate access.

This raises the prospect of doing something that Indiana started doing with its PDMP a couple of years ago -- and that a lot of other states want to do. The Hoosier State made it possible for prescribers to communicate with other prescribers about patients—so, if prescriber B sees a patient and discovers that Prescriber A has prescribed before, B can contact A and make arrangements for which one of them is going to follow the patient. Notes also can be left behind for other providers, for instance, if an ER doc gets a doctor shopper, he can leave a note about it so others are forewarned.

What about pharmacists? What’s their role? Should they have broader access to patient data?  Beyond being deputized by the DEA, the pharmacy community must be able to play a more appropriate role as a healthcare professional.

Perhaps one of the toughest issues is the role of abuse deterrent formulations (ADF). Beyond the debate over whether the FDA should insist that all generics be abuse deterrent (and the related IP debate), how should PDMPs instruct physicians and pharmacists? And what about formularies? Can we trust physicians to make the right call? Do all patients need abuse deterrent formulation? And, if not, what are the decision criteria? What about dose and duration limitations?

Or should there be state regulations per ADFs at all? Shouldn’t those decisions reside within the FDA? Can you say federal preemption?

This places both education (of the CME variety) and best practices (developed not just by PDMPs but also by physicians, pharmacists, and patient organizations) front and center. What about REMS training? And what about more precise criteria for what a “pain specialist” or a “pain clinic” even mean? As the saying goes, “if you can’t measure it, then it doesn’t count.”

What about take-back programs? Should they only be limited to opioids? And who should pay for them?

Lastly, amercement. On a state-by-state level, does the punishment fit the crime? Should there be national standards on criminal and civil penalties?

Many tough questions – but they deserve thoughtful and timely answers. It’s time for a focused national dialogue that recognizes the need for effective oversight through the use of Big Data and broader constituent alliances.

The conventional view serves to protect us from the painful job of thinking.

-- John Kenneth Galbraith

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Guidelines, Goalposts, and Genotypes

09/11/2013 09:15 AM |

Pierre Trudeau once said, “There's no place for the state in the bedrooms of the nation.“ But what’s the appropriate place for the state in our nation’s pharmacies and medicine chests – particularly for opioids?

Yesterday was the day to address that question.

First there was the FDA’s announcement of class-wide labeling changes and new post-market study requirements for extended-release and long-acting opioids.

Until now, the FDA had said the drugs were appropriate for the treatment of "moderate-to-severe" pain. The new drug label drops the word "moderate" and says it should be used only to manage "pain severe enough to require daily, around-the clock, long-term treatment." Additionally, FDA is adding a boxed warning on the risk of neonatal opioid withdrawal syndrome.

The agency said manufacturers must conduct one or more post-marketing studies to quantitatively estimate the risks of misuse, abuse, addiction, overdose and death associated with long-term use, as well as a clinical trial to evaluate the risk of developing increased sensitivity to pain with long-term use of extended-release and long-acting opioids. Companies also must conduct a study of "doctor/pharmacy shopping" -- a practice in which patients visit multiple doctors and pharmacies to obtain prescriptions -- and whether it is "suggestive of misuse, abuse and/or addiction." Per a report in BioCentury, “FDA said companies should work together on the post-marketing studies.”

Once the labeling changes are finalized, FDA said it will modify the classwide REMS for extended-release and long-acting opioids. The REMS, which the agency approved in 2012, requires companies to make educational programs available to prescribers at no or nominal cost but does not require prescribers to participate and does not include a prescriber registry.

The other big new was a Capital Hill conference on Personalized Medicine and Responsible Access to Pain Medication (sponsored by the Center for Medicine in the Public Interest – the think tank home of drugwonks.com). I was honored to chair the event.

Speakers included Bob Twillman of the American Academy of Pain Management, Cindy Steinberg of the US Pain Foundation, Stuart Kim of Mallinckrodt Pharmaceuticals, Steve Usdin of BioCentury, syndicated healthcare columnist Judy Foreman, and Professor Charles Inturrisi of Weill Cornell Medical Center.

The speakers and attendees rocked the Rayburn Building. Video of the event will soon be posted on the CMPI website.

I tried to set the tone with my opening comments:

Joshua Lederberg, the Nobel Prize Laureate once observed that the failure of regulatory, legal and political institutions to integrate scientific advances into risk selection and assessment was the most important barrier to improved public health.  

Lederberg noted that in the absence of such changes,  "the precedents affecting the long-term rationale of social policy will be set, not on the basis of well-debated principles, but on the accidents of the first advertised examples."

Policies and regulations that seek to limit risk are often shaped by the immediate fear of sensational events. This perspective is commonly called "The Precautionary Principle" which in various forms asserts that unless innovators can demonstrate that a new technology is risk free, it should be not allowed into the marketplace.  Moreover, any product that could possibly be dangerous at any level should be strictly and severely regulated. 

But precaution is not always safer than the alternatives.

Some current examples of precaution and the public health

·      The National Action Plan for Adverse Drug Event Prevention, just announced in a Sept. 4 Federal Register notice, outlines a comprehensive strategy to reduce AEDs for opioids. Much of the research actions called for by the plan seem designed to decrease prescribing. For instance, the plan calls for research by CDC, NIH and, public-private collaborations to look into adopting adjunctive and behavioral modalities to augment and reduce opioids use for chronic pain;

·      Upscheduling and the relabeling of medicines to treat depression, diabetes, chronic and acute pain;

·      And, finally, the role of tamper-resistant technologies in the appropriate management of pain medicines (both innovator and generic).

It’s also important to consider the DEA’s “Thug Regulation” strategy that results in a decline in appropriate patient access; an increase in regulatory time and cost and, ultimately, a decline in innovation.

The California Medical Association has received reports from physicians that Walgreens pharmacists are refusing to fill controlled substances prescriptions without additional information from the prescriber.

Per dictates from the DEA, Walgreen’s pharmacists are now demanding that physicians provide information on diagnosis, ICD-9 codes, expected length of therapy and previous medications tried and failed.

In other words, tighter restrictions for patients who really need the medications, more paperwork for physicians and a heavier workload for pharmacists. Abusers and criminals rarely follow regulations.

When you have a hammer, every problem looks like a nail. The DEA sees opioid abuse and seeks to minimize access to them. That’s a law enforcement solution. They mean well – but are behaving like a bull in a china shop

Arbitrarily limiting choice is not generally associated with the Scientific Method.

Should regulation be shaped by factors other than science or should advances in medicine and digital information be used to right-size regulation, reduce the excessive reductionism that leads to regulatory overreaction and promote resilience rather than ever increasing restrictions?

Consider the program recently instituted by CVS (and detailed in a recent New England Journal of Medicine Perspective piece) where, via the use of “Big Data” the chain pharmacy identified “outlier prescribers” and took appropriate and responsible actions.

The DEA’s attempt to deputize pharmacists on the one hand and the CVS program on the other raise some interesting questions:

·      What will the role of the 21^st century pharmacist be in improving drug safety and medication adherence via more proactive (and remunerated) patient education?

·      How can pharmacists become better integrated (beyond Med Guides) into the FDA’s Safe Use of Medicines initiative?

·      When will pharmacy synchronization programs really kick into gear, and how will states help to jump-start these important initiatives?

To paraphrase the American political scientist Aaron Wildavsky, we at the Center for Medicine in the Public interest believe in a strategy of resilience based on experience. We must learn from adverse consequences in order to develop a capacity to advance the public health. Variability is the key to survival.

THANK YOU.

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Peg's PAG

09/06/2013 11:48 AM |

From: CDER Center Director

Sent: Friday, September 06, 2013 11:24 AM

To: FDA-CDER-wide

Subject: FDA Establishes the Program Alignment Group

CDER Staff:

In order for FDA to best adapt to the ongoing rapid changes in the regulatory environment, driven by scientific innovation, globalization, the increasing complexity of regulated products, new legal authorities and additional user fee programs, the Commissioner has formed a Program Alignment Group (PAG). Comprised of senior Agency leaders, the PAG is charged with identifying and developing plans to modify FDA’s functions, processes, and possibly its structure in order to address these matters and best achieve mission-critical Agency objectives. This group of senior leaders will achieve this goal by working together to promote the strategic, operational, and resource management alignment needed for FDA to continue to fulfill its mission. 

As a member of the PAG, I am pleased to share with you the email and memo (below) that I received from the Commissioner this morning. This initiative will provide an opportunity for CDER to continue modernization of operations in order to address the challenges noted above and to implement our new legislative responsibilities, including those imposed by the Food and Drug Administration Safety and Innovation Act and the Generic Drug User Fee Amendments of 2012 (GDUFA).

Many of CDER’s current modernization efforts center around the regulation of pharmaceutical quality. Most of you are aware of the proposed elevation of the Office of Generic Drugs to a super office, and the concomitant efforts to establish a new Office of Pharmaceutical Quality (OPQ). The work to establish OPQ will need to be closely coordinated with the Office of Regulatory Affairs (ORA). We recognize that in order to accomplish GDUFA and other commitments, CDER and ORA need to have an integrated program for regulating pharmaceutical quality, with well-defined leads, coherent policy and strategy development, well-designed and coordinated policy implementation, and a de-layered management structure. Moving toward this new model will take time and a level of organizational change across CDER and ORA, including streamlining management and decision making and clarifying roles and responsibilities, metrics and accountability, and decision rights. Similar considerations apply to other inspectional programs.

I am confident that any changes implemented as a result of this evaluation will not only improve efficiency in our program areas and in our collaborations across the Agency, but also provide us with a solid foundation that allows us to continuously adapt to the ever-changing challenges and new demands placed on CDER. This is important as we continue to meet our critical public health and regulatory mission to ensure safe, effective, and high-quality drugs are available to the American public.

I look forward to participating in the PAG discussions. The first report from the PAG is due to the Commissioner in the next several months. FDA will then assess the recommendations and decide how to proceed. I am committed to keeping you informed about the outcome of the PAG’s evaluation; you may expect additional communications from me once the Agency determines its next steps in this process.

Janet Woodcock

From: Hamburg, Margaret


Sent: Friday, September 06, 2013 10:09 AM


To: Dunham, Bernadette M; Landa, Michael; Midthun, Karen; Plaisier, Melinda K; Shuren, Jeff; Solomon, Steven M; Taylor, John M.; Taylor, Michael R; Woodcock, Janet; Zeller, Mitchell


 Subject: Program Alignment Group

Over the past few years, FDA has experienced unparalleled challenges and demands posed by the increasing breadth, depth, and complexity of the products it regulates.  That, combined with significant strides in scientific innovation and increased biomedical discovery, the globalization of the food system and medical supply chains, as well as the expansion in FDA’s regulatory authorities via many new forms of legislation, require the Agency to continue to find ways to ensure that we are meeting our critical public health and regulatory mission. 

Therefore, to be in the best position to effectuate the steps necessary to successfully address these challenges, I am pleased to formally appoint you to the Program Alignment Group (PAG).  The PAG will be comprised of senior Agency leaders charged with identifying and developing plans to modify FDA’s functions and processes in order to address the challenges noted above and to best achieve mission-critical Agency objectives.  This group of senior leaders will attain this goal by working together to promote the strategic, operational, and resource management alignment needed for FDA to continue to fulfill its public health mission. 

More information about the PAG can be found in the attached memorandum.  The group will look at what changes may be necessary from an operational standpoint to transform the Agency from a domestic Agency operating in a globalized world to a truly global Agency fully prepared for a regulatory environment in which product safety and quality know no borders.

I want to thank you, as senior FDA leaders, for engaging in this important work together to move FDA into the future as a modern and globalized public health-regulatory Agency.  I look forward to watching your progress in the months ahead as we embark on this path together.

Margaret A. Hamburg, M.D.

Commissioner of Food and Drugs

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What can (Jerry) Brown do for you?

09/06/2013 10:30 AM |

The California Senate passed a state bill that would impose restrictions on when pharmacists may dispense a biosimilar in place of an innovator product. The California Assembly already passed the bill, which will now be sent to Gov. Jerry Brown. A spokesperson for Brown said the governor does not comment on pending legislation, but Brown will have until Oct. 13 to sign the bill into law.

The California bill would allow substitution of a biosimilar for an innovator product only if FDA declared the biosimilar interchangeable for the specific use; the prescriber had not expressly prohibited use of a biosimilar; the substitution was communicated to patients; the cost to the patient was the same or less than the innovator product; and the pharmacist notified the prescribing physician within five days. The requirement for physician notification would sunset after three years (Jan. 1, 2017). Additionally, the California State Board of Pharmacy would maintain a list of biosimilar products FDA determines to be interchangeable on its website. A spokesperson for the Biotechnology Industry Organization (BIO) said the bill applies only to retail pharmacies.

Despite what you may read in the papers, sometimes legislation that’s supported by innovator pharmaceutical companies is also in the best interest of the public health. This is one of those times.

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Avec Plaisier

09/04/2013 07:27 AM |

Dear Colleagues:

I am very pleased to announce the appointment of Melinda “Mel” Plaisier as the Associate Commissioner for Regulatory Affairs (ACRA), effective immediately.  As many of you know, Melinda has been steadfastly serving in this position in an acting role since October 1, 2012.  During that time, Melinda has led the Office of Regulatory Affairs (ORA), utilizing her deep operational knowledge, her proven leadership skills, and her professional and collaborative demeanor.

Melinda brings a wealth of experience to this position.  She joined FDA in 1995, after serving as a Congressional staffer for more than a decade.  Melinda spent more than 13 years in the Office of the Commissioner where, among other roles, she served as the Associate Commissioner for Legislation, providing executive leadership in directing and managing the Agency’s congressional relations and legislative activities, and the Associate Commissioner for International Programs, where she focused on negotiating international agreements and working with developing nations.  Immediately prior to serving as the Acting ACRA, Melinda served as the Regional Food and Drug Director for ORA’s Central Region for several years.

Melinda will report directly to the Deputy Commissioner for Global Regulatory Operations and Policy and will lead the 4300 extraordinary men and women of ORA who are dedicated to furthering FDA’s public health mission in many important ways, including by inspecting regulated products and manufacturers, by conducting sample analysis on regulated products, and by reviewing imported products offered for entry into the United States.

Going forward, Melinda will play a critical role in helping FDA adapt to the continuing program-based specialization within FDA’s regulated industries and in implementing FDA’s expanded authority in recent groundbreaking legislation in many important areas.  I am confident that Melinda will help position FDA as a public health regulatory agency fully prepared to deal with the many challenges of an increasingly complex global regulatory environment.

Please join me in congratulating Melinda as she assumes this official role.

Sincerely,

Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs   Read More & Comment...

Tweeter Reflux

09/03/2013 09:50 AM |

What part of "unbranded" didn't you understand?

AstraZeneca has pulled paid advertisements on the Associated Press’s Twitter feed after it was made aware that the unbranded content it believed it paid for actually included the name of a prescription drug.

Note – “paid advertisements.”

Per the Pink Sheet, “At first glance, two Aug. 27 tweets sponsored by AstraZeneca read like straightforward disease awareness ads, but when the tweets are expanded, they reveal the name of its acid reflux treatment Nexium(esomeprazole), appearing to place the company in a more heavily regulated landscape.”

On Aug. 27, the Associated Press ran a tweet sponsored by the pharma on the micro-blogging site that permits 140 character messages including links to websites or pictures. The tweet read: “Sponsored Tweet: 15M+ Americans experience #GERD symptoms each day. Visit AstraZeneca’s YouTube channel bit.ly/1aZ6BiK.”

At the bottom of the tweet users can click a “view summary” tab that pulls up an expanded version of that tweet. This expanded version includes a preview of the YouTube site the company links to: “the official YouTube channel of Nexium (esomeprazole mangesium).”

So the question becomes, when these two components are placed side-by-side, are they still the “unbranded tweets” the company thought it was posting?

Per AZ, the tweets are unbranded and were not sent to FDA for approval. The ads did go through all of AstraZenca’s own internal reviews and approvals to ensure compliance with applicable U.S. laws and regulations.

AstraZeneca: “The sponsored tweet we paid for was the tweet text itself. We weren’t aware that additional text would appear under a summary button. We are going to inform the FDA of this as soon as possible. We will also assess if any changes need to be made.”

That’s the key point – it was a “sponsored” tweet. In other words – a paid advertisement. This isn’t about social media. It’s the same issue that arouse over the FDA letters regarding “sponsored” Google links. “Sponsored” means paid – and “paid” is not social media.

So, please hold the hyperbole about the FDA retarding the use of social media.

Speaking of hyperbole, OPDP panjandrum Thomas Abrams said in late June that the long-awaited guidance is one of the highest priorities for the agency in terms of time and resources.

Down boy.

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