Latest Drugwonks' Blog
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.
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.
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.
