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In a comment filed in response to FDA's proposal, the FTC said distinct suffixes could lead physicians to believe biosimilars differ from their reference products in clinically meaningful ways.

This is precisely what was expected after the FTC’s February 2014 hearing on the topic – the one where the FDA wasn’t invited to testify. If there had been an FDA speaker, there might have been appropriate comments about the FDA's Pharmaceutical Science and Clinical Pharmacology Advisory Committee that debated and determined that the bioequivalence specifications should be tightened for, among other categories, generic versions of epilepsy medications – and that FDA officials presenting at that adcomm signaled strong agency support for the move.

The FTC even ignored it’s own expert commentary. In it’s 1979 report on generic drug substitution, the FTC concluded, “increased communication (as well as lower prices) may explain why most pharmacists report that product selection laws have had a positive effect on their relations with patients”

Safety and trust and exactly why differential naming is needed. As Sumant Ramachandra, Senior Vice President & Chief Scientific Officer of the biosimilar manufacturer Hospira, said at the FTC hearing, “Communications fosters confidence.”

The facts speak for themselves (even if they didn’t get a chance at the FTC event). A poster presentation from the European Crohn’s and Colitis Organisation, titled, “Biosimilar but not the same,” offers some timely and important real-world data on the differences between originator biologics and their biosimilar cousins.

The study, from Mercy University Hospital, University College Cork, Centre for Gastroenterology, Mercy University Hospital, Cork, Ireland, studied the clinical impact of both the innovator product (Remicade) and it’s EMA-approved biosimilar (Inflectra). The findings are important. Specifically, the rates of surgery in Infliximab and Inflectra groups were significantly different.

80% of the Inflectra group required hospital readmission versus 5% of the infliximab (Remicade) group. (p=0.00004). 60% of patients in the Inflectra group needed steroid augmentation of standard steroid tapering protocol with 50% requiring multiple increases in steroid dose versus 8% of patients in the Infliximab (p-value = 0.0007). Over the course of 8 weeks, 93% of patients in the Inflectra group had an increase in CRP with 7% remaining unchanged whereas 100% of patients in the infliximab group had a decrease in CRP (p=<0.001).

The conclusion is not ambiguous, “Our results suggest that biosimilars may not be as efficacious as the reference medicine. The results found reflect the ECCO statement position that the use of most biosimilars in IBD will require testing in this particular patient population and cannot be extrapolated from other disease populations."

The complete poster can be found here.

These First World data points about a product from a respected manufacturer (Hospira) cannot be ignored and must be used to inform the policy debate over nomenclature, interchangeability, label extrapolations, and overall pharmacovigilance practices.

Does the FTC believe that safety and outcomes are a constraint to competition?

That’s a comment worth repeating.

An editorial in the New England Journal of Medicine endorsed Robert Califf for FDA commissioner. Written by Editor-in-Chief Jeffrey Drazen, the editorial rejected criticisms of Califf's nomination due to his industry ties, saying that "it is impossible to argue that Califf has a pro-industry bias" based on the outcomes of industry-sponsored clinical trials in which he was an investigator
The Kaiser Family Foundation ran another health care survey that asked if people wanted price controls on drugs.  As I wrote after the last KFF price control poll the results are not suprising and consistent with surveys on the subject taken over 50 years.  

Let's set aside the fact that people have also supported price controls on hospitals, gas, oil, cable TV rates, etc.  The polls this time around are being used as part of a broader campaign to impose price controls on a state level and to get the next president to "do something" through executive order.  

Where is a poll that asks people what they think PBM and insurer cost sharing strategies.  In particular, where is the poll taken  after massive negative coverage (similar to that dumped on drug companies) showing how "PBMs to create a preference for drugs and generics that yield the greatest rebates and
profits. What is more, this arrangement actually incentivizes PBMs to promote the drugs for which they receive the largest per-prescription rebate,
rather than the cheapest or best-value prescription."  Or that insurers will pocket rebates and then force consumers to pay up to 40 percent of the cost of the rebated drug.  Or that insurers will create step therapy programs that reinforce their profit margin.

Don't you think Phrma should conduct it's own poll about price controls?  Guess what?  It did.  But the media ignored it as biased.  And a one and done poll will never get traction if it isn't part of a broader conversation. 

The industry will never get the media to cover this.  So it's up to them to invest time and money in a real campaign.  It had no problem forking over $150 million to the campaign to pass Obamacare.  You'd think they'd find the ability and resources to do the same to put drug prices in proper perspective.

If the industry thinks playing nice with it's opponents will work, it will be inviting price controls.   I don't  know how many times I have heard from pharma that they can't attack PBMs and insurers because they are "our" customers.   Meanwhile their customers are deeply involved in pushing price controls and running tough negative media campaigns against them.

There's a point at which concililation and civility is taken too far.  Past that point, it becomes defeat by default.

The collection of companies that comprise the biotech and pharma industry has developed and commercialized more important products than any known to humankind.  It -- and the hundreds of thousands of scientists working for them -- deserve better than to be treated like predators.  

Ben Levisohn from Barron's discusses an analyst's report regarding the FDA's warning about Viekira Pak, one of the newer Hep C drug's.  

"Yesterday the FDA warned that Hep C treatments with Viekira Pak can – in some cases – cause serious liver injury mostly in patients with underlying, advanced liver disease. We believe this disclosure will impact some physician prescribing and drive incremental share shift to Gilead’s Hep C drugs. At the beginning of the year, Express Scripts positioned Viekira Pak as the exclusive option on its National Preferred Formulary (NFP) for patients with genotype 1, and we view this announcement as an incremental negative for Express Scripts. While Express Scripts also has access to Gilead’s (GILD) drugs (e.g., Sovaldi and Harvoni), we estimate that Express Scripts generates higher rebate dollars and profitability from Viekira Pak."

Note:  the reason for forcing patients to fail first on Viekira Pak before being 'allowed' to pay for another drug is to maximize profits.  

Two questions:

First, how many other step therapy or fail first protocols -- structured to maximize rebates and profits --  are exposing patients to drugs that could injure or kill them?  CMPI will be looking into this issue.  In depth. 

Second, I wonder what the ASCOs and oncologists posing as economists will do since they have essentially rallied around 'value' frameworks that extend the Express Scripts Hep C approach to cancer patients.  A few months ago,  these 'experts' were more than happy not only to put the seal of approval on fail first but also help design them.  

As in Peter Bach tweeting Thrilled @ExpressScripts to operationalize my Indication specific pricing model for cancer drugs    As in "clinical trial data and input from experts like Dr. Peter Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center, will shape Express Scripts' further strategy."

If you are going to be thrilled about the operationalization, you should be willing to accept responsbility for the harm done when adopted.  


The Marine Corps Marathon is being run this weekend in Washington, DC.   The whole idea of a marathon never made sense to me.. why run that far when we have cars to get you there faster?   

But that was before I met Don Wright.  Don is 74 and running in his 90th -- as in just 10 less than a 100 -- marathon.  

Oh, and Don has had multiple myeloma since 2004.  

I met Don about 40 marathons ago in 2012.   He had just finished running his 50th marathon in Hawaii, which was the 50th state in which Don has completed such a race. 

He was diagnosed with the disease 12 years ago when his doctor told him that he had about 4 years to live, max.  Back then, all he wanted to do was run one marathon. He was fortunate enough to be put on an experimental medicine (now approved) that knocked the disease into remission.   As he has said more than once (but never enough)" It's just a little.. pill that I take every night."  Earlier this year Don was worried that he wouldn't be well enough to run the Marine Corps event.  It wasn't cancer.  He had a pulled hamstring from overtraining!

I have had the deep privilege of spending time with Don.  He is a powerful voice for medical innovation, a loving and dedicated husband and father and a source of comfort and support for everyone reeling from the diagnosis of a deadly disease.  

The greater marathon runner Bill Rogers once said, "the marathon can humble you."   Don Wright has shown that it can inspire us as well. 

The American Academy of Pain Management sent this letter to the chair and key members of the House Energy and Commerce Committee, regarding the flawed process used by CDC in developing its opioid prescribing guidelines. The letter was also sent this letter to the chair and ranking member of the Senate HELP Committee.

The letter details the most important methodological shortcomings in CDC’s process, and asks that the committees investigate to determine why a more robust and appropriate procedure was not followed. Finally, the Academy asks the committees to suggest to CDC that they scrap this guideline and start over, using a more inclusive process.

This issue is not going away.

An excellent piece by Razelle Kurzrock and Hagop Kantarjian among others, that puts the price of drugs in proper perspective.  The faster we bring medicines to market using new tools that promote precision medicine, the less expensive it will be to develop these medicines.  And the less expensive it is, because of greater certainty of benefit, the more investment (and competition) there will be. 

See what happens when regulation doesn't get in the way of producing valuable technologies?

Let's hope that this important article can be the foundation for a broader effort to promote faster, less expensive access to new medicines. 

The Urgent Need for Clinical Research Reform to Permit Faster, Less Expensive Access to New Therapies for Lethal Diseases
October 19, 2015

Written by David J Stewart, Gerald Batist, Hagop M. Kantarjian, Joan Schiller, John-Peter Bradford, Razelle Kurzrock

Technical Abstract

High costs of complying with drug development regulations slow progress and contribute to high drug prices and, hence, mounting health care costs.  If it is exorbitantly expensive to bring new therapies to approval, fewer agents can be developed with available resources, impeding the emergence of urgently needed treatments and escalating prices by limiting competition.  Excessive regulation produces numerous speed bumps on the road to drug authorization.  Although an explosion of knowledge could fuel rapid advances, progress has been slowed worldwide by inefficient regulatory and clinical research systems that limit access to therapies that prolong life and relieve suffering.  We must replace current compliance-centered regulation (appropriate for nonlethal diseases like acne) with “progress-centered regulation” in lethal diseases, where the overarching objective must be rapid, inexpensive development of effective new therapies.  We need to (i) reduce expensive, time-consuming preclinical toxicology and pharmacology assessments, which add little value; (ii) revamp the clinical trial approval process to make it fast and efficient; (iii) permit immediate multiple-site trial activation when an eligible patient is identified (“just-in-time” activation); (iv) reduce the requirement for excessive, low-value documentation; (v) replace this excessive documentation with sensible postmarketing surveillance; (vi) develop pragmatic investigator accreditation; (vii) where it is to the benefit of the patient, permit investigators latitude in deviating from protocols, without requiring approved amendments; (viii) confirm the value of predictive biomarkers before requiring the high costs of IDE/CLIA compliance; and (ix) approve agents based on high phase I–II response rates in defined subpopulations, rather than mandating expensive, time-consuming phase III trials.  Clin Cancer Res; 21(20); 4561–8. 2015 AACR.

Towards a More Intramural Approach to Biomarker Development

A recent article by Shashi Amur and FDA colleagues on the future of biomarker development (Biomarker Qualification: Toward a Multiple Stakeholder Framework for Biomarker Development, Regulatory Acceptance, and Utilization) provides a solid foundation for ongoing development and review process for biomarker qualification. FDA should be applauded for their progress in agency collaboration with the Critical Path Institute (in biomarker consortia development), the recent total kidney volume and plasma fibrinogen prognostic marker approvals, and sponsorship of interactive sessions such as the recent CERSI meeting at University of Maryland, as well as their EMA partnership to facilitate collaborative review of drug development tool qualification.

We would encourage additional measures to hasten biomarker development, including:

  • Maximizing Expert Resources: FDA needs adequate resources to provide advice and oversee review and decision-making. One solution is to partner with an external entity (an Intramural Biomarker Consortium-IBC) to develop early advice and serve as an expert sounding board for nascent biomarker efforts.  The IBC could be a required or voluntary resource in the review process, especially for initial data package reviews. This approach would allow FDA staff to focus on their primary role of product review and regulatory oversight.
  • Refined Evidentiary Considerations: The product development and research community should collaborate to support FDA in developing a framework for the proper level of evidentiary substantiation required for qualification and the criteria used to evaluate them – such that FDA can issue guidance -standards which do not exist today.  The IBC could be charged with overseeing relevant workshops and the drafting of initial guidance documents (consistent with FDA’s Good Guidance Practice recommendations and provided FDA is actively participating and has final approval).
  • Qualification Plan: FDA should clarify the components of individual qualification plans and judge submitted data packages against them.  Decisions not to qualify a proposed biomarker for a particular context should be accompanied by an explanation of the evidentiary gaps between the agreed plan and the submitted qualification package. IBC could work with biomarker developers to build these plans and perform initial data package reviews.
  • Enhance Learning:  Give FDA the authority to share information about biomarker qualification programs that are being advanced through collaborative efforts. Much can be learned by reviewing successes and failures across ongoing biomarker programs, and would inform the broader research community to enable refined evidentiary standards.
  • Timeliness: FDA must clarify and communicate timelines for the qualification process in order to foster predictability and encourage participation.  Such resources could be provided via PDUFA VI.

FDA can further solidify its place squarely in the center of the innovation ecosystem by fostering collaborative alliances with all stakeholders, enhancing qualification planning, sharing developmental endeavors, and clarifying standards.

Peter J. Pitts
President, Center for Medicines in the Public Interest
Former FDA Associate Commissioner

Timothy R. Franson, M.D.
Chief Medical Officer – YourEncore
Immediate Past President- US Pharmacopeial Convention

Health plans and pharmacy benefit management firms are hiking co-insurance rates for new medicines.  As Adam Fein points out in his Drug Channels blog,  they are daring biopharma companies to NOT provide copay assistance which can amount up to 25 percent of the total cost of a drug.  (Federal programs like Medicare Part D don't allow patients to get such support directly.)  

Moreover, rebates cost biopharma about $40 billion each year.  Nearly 90 percent of that $40 billion ($36 billion) is passed on to health plans by PBMs.   In 2014,  health insurers generated  $663 billion in revenue, which means drug rebates are about 5 percent of total revenues.  

I now see another layer to the strategy of make drug prices, which are effectively set by PBMs and insurers with higher coinsurance, the issue and blaming drug companies.  It's all about making money coming and going.   PBMs and insurers can extract deeper discounts from companies whose products they carry AND get the innovator firms to pay for the chunk that consumers have to cover:

Adam discussed an IMS study " Emergence and Impact of Pharmacy Deductibles: Implications for Patients in Commercial Health Plans"  As he notes: "The report’s overarching theme is unsurprising: Higher out-of-pocket costs reduce patients’ adherence to drug therapy and increase prescription abandonment rates.

The report’s major contribution, however, links the growth in pharmacy deductibles to manufacturers’ copayment offset programs, which cover a beneficiary’s out-of-pocket costs for a brand-name drug. High deductible plans are shifting costs from payers to consumers and—in many cases—back to manufacturers.

The findings echo what payers have been doing by adding coinsurance rates to higher-tier products, per Employers Get Tougher About Pharmacy Benefits and Specialty Drug Management. Most people can’t afford to pay hundreds or thousands of dollars every month. Payers are therefore essentially daring pharmaceutical manufacturers not to pick up the patient’s coinsurance with a copayment offset program. This is the same dynamic that links the growth in four-tier benefit plans with copay offset program. See How the Fourth Tier Coinsurance Boom Drives Copay Offset Programs.

I’m not sure how many manufacturers have analyzed the codependent relationship between benefit design and their consumer-directed programs. This report suggests that such analysis would be truly therapeutic."

To which I would add.. maybe the innovators should show consumers how their drugs are priced by insurers to force them to cover the difference and suggest how patient hostile such an approach is.   This co-dependency undermines the doctor patient relationship and moves medicine away from the kind of personalized treatment selection medical innovation is making possible.  


  • 10.20.2015

Wither FDA?  Also, what about addressing incentives/responsibilities for enhanced physician/pharmacist/patient reporting?

From the pages of FDA News ...

EMA Releases Pharmacovigilance Program Update

Drugmakers must begin using a new centralized database for product safety update reports by mid-2016, the European Medicines Agency says.

The updated repository will also link the PSUR single assessment procedure number with products, making searches easier, and will allow for an automated two-way exchange between national authorities’ IT systems and the PSUR repository.

Use of the repository becomes mandatory on June 13, 2016. Until then, marketing authorization holders must continue to submit PSURs to national competent authorities.

The EMA is also finalizing revisions to its EudraVigilance Access Policy, which would give drugmakers greater access to adverse event reports, beginning in mid-2017. The agency’s management board is set to vote on the policy in December.

The EudraVigilance website will be updated in November with the publication of key documents such as the Stakeholder Change Management Plan, which details the IT and business changes companies need to make before reporting begins, the EMA says.

The EMA also plans to release a report this month on the launch of its Medical Literature Monitoring initiative, which allows drugmakers to easily search for information on adverse reactions associated with their products.

In addition, the EMA has launched an online invoice portal where companies can pay their annual pharmacovigilance fees. Under the fee program, which took effect in July, drugmakers must pay $70 for each product they market in the EU.

The agency has also updated its database of 500,000-plus drug products and is giving member states access to it. Drugmakers should enhance their in-house systems to allow for receipt of acknowledgment messages regarding new and modified marketing authorizations, beginning Nov. 4.

The changes were mandated in the 2012 pharmacovigilance legislation. View the EMA’s Pharmacovigilance Program Update at

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.

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