A 2010 USFDA update titled ‘Generic Competition and Drug Prices’ highlighted that generic competition is intimately associated with lower drug prices, and the entry of the second generic competitor is associated with the largest price reduction.
The agency found that on an average, the first generic competitor prices its product only slightly lower than the brand-name manufacturer. However, the appearance of a second generic manufacturer reduces the average generic price to nearly half the brand name price. As additional generic manufacturers market the product, the prices continue to fall, but more slowly. For products that attract a large number of generic manufacturers, the average generic price falls to 20 percent of the branded price or even lower.
USFDA came to this conclusion based on an analysis of IMS retail sales data for single-ingredient brand name and generic drug products sold in the United States from 1999 through 2004.
Thus, the scope of any significant price increase, especially under cutthroat competition in the generic space of the US, used to be considered almost impractical until recently.
The ‘Myth’ busted:
Just over four years down the line, a ‘Press Release’ of the Committee on Oversight and Government Reform shattered this myth, when on October 2, 2014, Rep. Elijah E. Cummings, Ranking Member of the House Committee on Oversight and Government Reform, and Senator Bernard Sanders, Chairman of the Subcommittee on Primary Health and Aging, Senate Committee on Health, Education, Labor and Pensions, sent letters to 14 drug manufacturers, which reportedly include India’s Sun Pharma, Dr. Reddy’s Laboratories and Zydus Cadila, requesting for detail information about the escalating prices for generic drugs that they have started charging.
The letters:
The complete letters written to each of the 14 drug manufactures are linked below:
PAR Pharmaceuticals Companies Inc.
Sun Pharmaceutical Industries, Inc
Teva Pharmaceutical Industries Ltd.
West-Ward Pharmaceutical Corp.
Zydus Pharmaceuticals USA Inc.
Summary findings of apparently ‘obscene’ price hike:
The following statements of Rep. Cummings and Senator Sanders capture the core sentiment of the probe:
“When you see how much the prices of these drugs have increased just over the past year, it’s staggering, and we want to know why,” Cummings said.
“Generic drugs were meant to help make medications affordable for the millions of Americans who rely on prescriptions to manage their health needs. We’ve got to get to the bottom of these enormous price increases,” Sanders added.
In the above letters, Cummings and Sanders quoted data from the Healthcare Supply Chain Association on recent purchases of 10 generic drugs by group purchasing organizations over the past two years. For example:
- Albuterol Sulfate used to treat asthma and other lung conditions, increased 4,014 percent for a 100’s bottle of 2 mg tablets.
- Doxycycline Hyclate, an antibiotic used to treat a variety of infections, increased 8,281 percent for a 500’s bottle of 100 mg tablets.
- Glycopyrrolate, used to prevent irregular heartbeats during surgery, increased 2,728 percent for a box of 10 of 0.2 mg/mL, 20 mL vials.
Click here for a table of price increases for the ten drugs examined.
The information sought by lawmakers:
The Lawmakers requested the companies to provide detail relevant information from 2012 to the present, including:
- Total gross revenues from sales of the drugs,
- Prices paid for the drugs,
- Factors that contributed to decisions to increase prices,
- The identity of company officials responsible for setting drug prices.
The trigger factor:
This probe by the US lawmakers was triggered by the National Community Pharmacists Association (NCPA) 2013 survey of drug prices. Subsequently in 2014, the NCPA had requested the US Senate to investigate into staggering increases of 390 – 8200 percent in the procurement prices of ten generic drugs, in just one year.
Immediate financial impact:
Reacting to this news, in the early afternoon on October 8, 2014, the scrip of Sun Pharma reportedly declined by 3.91 percent to Rs 804.10 and Dr. Reddy’s Laboratories slipped by 3.29 percent to Rs 2,996.90 while Cadila Healthcare was down by 1.84 percent to Rs 1,313.85 on the Bombay Stock Exchange (BSE).
It is too early to speculate on the ultimate outcome of this probe. However, it may not be prudent to rule out the possibility of a far-reaching consequence, besides levying of commensurate penalties to the respective drug manufacturers.
India too acted upon, but withdrew hastily:
For products falling outside Drug Price Control Order 2013 (DPCO), which account for around 82 percent of the total Indian Pharmaceutical Market (IPM) and are eligible for free pricing, India has a similar, yet slightly different problem.
The National Pharmaceutical Pricing Authority (NPPA) had addressed this issue recently, but was compelled to withdraw its internal guidelines on the subject rather hastily, coincidentally just prior to Prime Minister Modi’s visit to America. Pharma industry and its lobbyists had projected this move of NPPA as a regressive step in the free pricing space.
The above measure of the NPPA was related to arbitrary and wide price variation within the same non-schedule drug molecules, manufactured by different pharma companies. This was important, as unlike many other non-drug products, patients buy medicines based on what the doctors’ prescribe for them. Moreover, patients undergoing medical treatment or their relatives usually have no inkling about the availability of lesser price equivalents of the same molecule/molecules as recommended by their doctors.
For example, Glimeperide, an anti-diabetic drug, sold by the market leader at ₹133 for a pack of 10 tablets, despite other equivalent brands being available at or below ₹40 or the MRP for a pack of 10 tablets (40 mg) of Telmisartan, used to treat hypertension varies from a low of ₹25 to as high as ₹385.
More volume sales of many of these high price drugs, despite availability of their low price equivalents, manufactured by equally well reputed companies, are primarily driven by various differentiated activities of the pharma companies to influence the doctors in favor of their respective products, as believed by many. Such type of free market encouraging free drug pricing, devoid of any possibility for the patients to exercise informed choices on the medicine price, defeats its core purpose.
Thus, absurd price variation within the same formulation of the same product molecules, even after accounting for all imaginable reasons for the price differences, was construed by the NPPA as ‘market failure’, as consumers cannot use their choice in product selection. In a market situation like this, intervention of the government is warranted for the sake of public health interest.
I hope, the Supreme Court of India would take note of this situation, in its next hearing.
A critical Question:
Based on ‘The New York Times’ report, I twitted (#@tapan_ray) on October 8, 2014 as follows:
“It happens in the US too? Government Demands Reasons For Rising Generic Drugs Costs, Otherwise Industry To Face New Regulation. http://nyti.ms/1vMi4No”
Subsequently, on October 9, 2014, Indian media flashed headlines like:
- “Sun, Dr Reddy’s, Zydus Cadila named in US Congress price probe” or
- “Sun Pharmaceutical Industries, Dr. Reddy’s face US action on price hikes up to 8,000 percent”
In this scenario, where prices of some generic drugs sky rocket by 390 to 8,200 percent just in a year, the following basic question comes up for all stakeholders to ponder:
Does free pricing of drugs, even in free markets, work at all to protect patients’ health interest?
Conclusion:
In my view, quite unlike most other products, pricing freedom for medicines does not work in a free market due to a number of factors, even where intense competition exists from equivalent products placed in different price bands. This is mainly because, despite availability of lower price equivalents of the same or similar drugs, patients cannot exercise their pricing choice even within the same molecule, in any way, and is totally bound by what is prescribed by the doctors. This happens in India too and in all those countries where product substitution is illegal.
Moreover, it is an open secret that the pharma players heavily influence most of the heavy prescribers in their choice of drugs following various means. As a result, in many cases highest priced products become the category leader too, despite availability of lower price equivalents from equally reputed companies. This scenario makes many people believe that in a stable market situation drug prices skyrocket primarily due to dubious business practices giving rise to gross market manipulation
I reckon, just on drug pricing issue, many pharma players, both global and local, are inviting much avoidable business risks, not just in the developing markets such as India, but also in the largest free market economy of the world – the United States… or wherever opportunities for free drug pricing exist, irrespective of what it means to the patients. This mindset needs an urgent introspection, as the past would possibly not be replicated in the future.
Expectations from the civil society are now high that governments, both in the developing and also in the developed world, would keep a careful vigil to ensure that the process of earning a decent profit by the pharma players does not transgress into a limitless fetish for profiteering under any facade, pushing majority of patients succumb to life threatening ailments without having access to appropriate medicines. This defeats even the very purpose of drug innovation, as its access gets highly restricted mostly to the creamy layer of the society.
Many would consider this situation as grossly devoid of equity, unfair, unjust and in no away be allowed to continue. It is not an issue of taking moral high grounds either or scoring brownie points in a debate, but more importantly a critical ingredient to uphold ethics and values in pharma business, while re-creating its well-deserved public image, as it takes rapid strides towards inclusive growth.
By: Tapan J. Ray
Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.