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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
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.
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.
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.
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.)
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.
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.
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.
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
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.
