Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By



Executive Summary

Internatl. and Third World regulatory provisions that would limit new drug introductions to products therapeutically superior to or less expensive than those already available would create "insuperable" barriers to research and marketing in the developing world, PMA VP-Communications Frank Fowlkes maintained at an April 25 press briefing in Washington, D.C. With such a "better than or cheaper than" provision, Fowlkes contended, "you're raising the odds" of finding new compounds, "you're raising the costs of research," And "you're going to inevitably reduce the volume of research and you're going to reduce the number of new discoveries." The "market would shut down in that part of the world" where the provision was implemented, he declared. "The little bit of research that is done in that part of the world will just be put back in places where it would be profitable to put it." PMA held the press briefing in anticipation of the World Health Organization's (WHO) World Health Assembly meeting in early Mary in Geneva, Switzerland. Asserting that the issue of a "better than or cheaper than" regulation appears likely to come up at the assembly, PMA used the briefing to lay out its case against the proposal and rebut longstanding consumer criticisms of multi-natl. pharmaceutical company marketing practices. The assn. also reiterated its view that poverty and lack of an infrastructure are the key problems facing developing countries. Referring to his two trips to Africa, PMA President Lewis Engman asserted that "the real problems in those countries were not the way drugs were being sold or marketed, but the fact that there were not enough of them to go around." Fowlkes noted that the "better than or cheaper than" proposal is part of a marketing code developed and advocated by the consumer group Health Action Internatl. An effort to adopt the entire code was defeated at the assembly's 1983 meeting. While it previously appeared that the entire code would be put forward, it now seems "more likely' that the one provision will be proposed, Fowlkes said. "It may be called a code but limited to that better than or cheaper than formula. It may take the form of a resolution calling for expansion of the Action Program on Essential Drugs and with it the restricted formulary of some 250 drugs. It may take the form of a resolution calling for a Bangladesh-type solution, which really amounts to the same thing in a slightly different form - where they just comb their existing formulary and discard not just the junk but the me-too products." A policy that would only permit approvals of superior or less expensive products also fails to acknowledge that "me too" products do offer some medical advantages and price competition, Fowlkes asserted. The policy, he maintained, "would in short order create a monopoly" for the producer of the one "best or cheapest" drug. Allegations that multinatls. are responsible for "a lot of junk" on Third World markets seems to be emerging as "the most significant charge" by activists, Fowlkes asserted. The charge, he explained, is that "there are a lot of tonics and elixirs, me too drugs and generally redundant products which make it difficult for the consumer or the doctor to ascertain what product is the best for their patient and which is the cheapest." While such products do exist, "the vast majority" are produced by local firms, not multinatls., he maintained. PMA Internatl. VP Jay Kingham asserted that when Bangladesh removed about 1,700 products deemed unsafe and/or ineffective, 75% of the affected drugs were manufactured by Bangladeshi firms. Drug Industry Has Faced Challenges In "Host Of Forums Around The Globe" In Past 12 Months -- Kingham Multinatls. do not take issue with efforts to remove products "that are non-therapeutic and unsafe," Fowlkes stressed. However, he continued, "we do have a problem w hen they start taking off products which they call redundant, but which are safe and effective. Doing that will have some very serious long-run effects both on the quality of medicines and on the availability of medicines." Efforts to gain internatl. organization approval for a pharmaceutical marketing code must be viewed in the broader context of a conflict within the United Nations system over a developing world claim that it is "entitled to a massive redistribution of wealth that is concentrated in the industrialized nations," Kingham declared. "To the extent that this wealth and technology is produced or held by the private sector is the belief of many of these pope...that this redistribution can somehow be coerced through the internatl agencies or some other form of internatl. regulation," the PMA exec maintained. "Those of us who have been following these developments are convinced that the drug industry has actually been selected as a trial case of lead industry to be subjected to the internatl. economic order," he said. Industry counter-efforts within WHO have so far been successful, leading activists, principally the Internatl. Organization of Consumers Union and Health Action Internatl., to seek other forums for their proposals, Kingham said. "Over the last year, we've seen t hem redouble their efforts" and industry has faced potential regs "in a host of forums around the globe." For example, Kingham explained, at the United Nations Conference on Trade and Development meeting in June 1983,"buried in a month-long agenda, which was addressed by several thousand delegates," was a "developing country resolution calling for an all-encompassing pharmaceutical code, basically the" Health Action Internatl. code. (for a chart of key internatl. organization meetings where pharmaceutical regulatory proposals have been raised during the past 1q months, see chart, previous page.) Chart omitted.

You may also be interested in...

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts