HGAP ON FDA FAST TRACK, MAY 04 <TITLE> </HEAD> <BODY bgcolor=#ffffff BODY LINK="#333366" VLINK="#333360"> <UL><a name="top"></a> </a><font size=2><A HREF="http://www.healthgap.org ">Health GAP Home</a> | <A HREF="http://www.healthgap.org/press/press_index.html">Health GAP Press Center</a></font><BR> <HR> <font face=Verdana,Geneva> <FONT SIZE=2><P align=center><IMG SRC="../img/hgap_logo.gif"><P> <B>Health GAP</B><BR> <A HREF="http://www.healthgap.org/">www.healthgap.org</A></P> <B><FONT SIZE=2> PRESS RELEASE AND NOTE TO EDITORS </B><P> May 17, 2004 <BR> For more information, contact: Sharonann Lynch +1 646 645 5225 or Asia Russell +1 267 475 2645 <BR></FONT><BR><font face=Verdana,Geneva size=2> </B>  </P></FONT><B><FONT SIZE=4><P ALIGN="CENTER"><font face=Verdana,Geneva>  New F.D.A. Program to Approve AIDS Drugs for Poor Countries: <BR> Cover for Shutting Out Generics in U.S. Bilateral Program? </B></B></FONT> </FONT><B><FONT SIZE=2><font face=Verdana,Geneva> </B></FONT></B> <FONT><B><FONT SIZE=2><P ALIGN="CENTER"><font face=Verdana,Geneva>  </B></B></FONT> </FONT><FONT SIZE=2><font face=Verdana,Geneva> <P>  (Washington, DC) In an attempt to deflect mounting criticism of policies against using U.S. money to purchase generic AIDS drugs for use in poor countries hardest hit by HIV/AIDS, the U.S. government announced a FDA program for accelerated review of generic and brand-name AIDS drugs financed by the Bush's aid program, Presidential Emergency Plan for AIDS Relief (PEPFAR). Rather than a good faith effort by the U.S. to support the international consensus that already endorses procurement of quality assured generic products through the WHO prequalification project, activists say this new program is designed to shield the Administration from criticism while creating significant new hurdles for generic producers. <P> "While the US claims this plan will speed AIDS drug approval for use in the President's Emergency Plan for AIDS Relief, representing an shift in policy, in reality the FDA process will likely toe the administration line and end up a bottomless pit of enhanced approval criteria, aimed at shutting out generics from approval," said Paul Davis of Health GAP. "Brand-name medicines will continue to enjoy a monopoly, not only in U.S. markets, but now throughout the developing world through U.S. aid programs and U.S. trade agreements." <P> Activists caution the process requires generic manufacturers that have already proven the safety and efficacy of their product through passing WHO prequalification, to recreate key trials and submit to redundant plant inspections. According to draft guidelines, applications for generic versions of new products that have exclusivity as "new chemical entities," would be barred from consideration by the FDA. These include important new AIDS drugs that will be invaluable in treatment scale up efforts. <P> Generic versions of antiretrovirals are the least expensive option for scale- up of AIDS treatment in poor countries. The Clinton Foundation negotiated a price for generic triple combination medications from generic manufacturers for less than $140 per person per year. Already in use by national governments, UNICEF, World Bank, the Global Fund to Fight AIDS, TB, and Malaria, and private international relief organizations, these generic medicines have been used throughout developing countries to treat tens of thousands of people living with HIV/AIDS. However, US policies that block procurement of these generic AIDS medications threatens to undermine these new advances. <P> Activists claim the U.S. successfully stalled the PEPFAR program so that brand- name pharmaceutical companies to play "catch up" and announce plans for their own FDC to compete with generic versions of antiretrovirals that are currently the least expensive option for scale-up of AIDS treatment in poor countries. "The US, while appearing to finally find religion on this issue, continues to buy time to lock in countries and recipients into using only patented drugs," said Health GAP's Asia Russell. "This decision will cost money, time and lives." <P> The new system proposed by HHS will create a parallel process with different requirements, processes, and standards for drug approval than the WHO's project to approve medicines. "If it ain't broke, don't fix it," said Jen Cohn of Health GAP. "Even though the WHO pre-qualification program has the support of the international community, the US government is more interested in pleasing big pharma and stifling the use of generics medicines." <P> On May 18th AIDS Czar Tobias will give testimony on PEPFAR to the Senate Appropriations Subcommittee on Foreign Operations. Questions regarding the new FDA process and potential barriers to approval of generic drugs are expected, including: postmarking surveillance of products, regulations protecting clinical data of brand-name drug companies used to prove safety and efficacy, requirements to re-do tests for bio-equivalence, cost of submitting drugs for approval, and timeline and requirements for FDA inspections of manufacturing sites. <P> #30 <P> HEALTH GAP NOTE TO EDITORS<BR> May 17, 2004<BR> For more information, contact: Sharonann Lynch +1 646 645 5225 or Asia Russell +1 267 475 2645 <P> <b>State Department/HHS AIDS Drug Announcement: Unnecessary Program, New Barriers to Generics. </b><P> <i>Please note: due to this and other outrages against people with AIDS in the US and worldwide, over 1000 marchers and more than 100 arrests are expected at a demonstration on Thursday May 20 in Washington DC. The march steps off at 11am from Folger Park passed the RNC and DNC HQs to end at the Capitol Building for a civil disobedience demanding action from the next President of the United States. To discuss the march and rally and/or the new Bush Administration policy to erect new hurdles against generic medications in developing countries, call 215.833.4102 -- for press release & demands, see also http://www.champnetwork.org/index.php?name=May20 </i><P> 17 May 2003 <P> The Devil is authoring the details... <P> The unnecessary, duplicative, and burdensome process will require generic companies to jump more hurdles and will delay US procurement of medicines that have already been quality assured. <P> The requirements of the US approval process raise new barriers, in particular for important new single products and fixed dose combinations for which exclusive rights as a new chemical entity (NCE) are retained. Specifically tenofovir, atanazivir, and emtricitabine.Ê <P> At this point, the FDA would deny approval to either of those three products in a generic version or any generic FDC that contains those products. This creates an unacceptable barrier and must be corrected. <P> Furthermore, the new FDA rules contain obvious contradictions. There is no assurance from the US government that they will take a pro public health approach in resolving these contradictions. <P> For example: <P> If one or more of the approved drug components is covered by a patent, the FDA could not approve the 505(b)(2) application until the patent expires or, if the patent is challenged by the 505(b)(2) applicant and the applicant is sued, for 30 months or until the patents are declared invalid or not infringed by a court, whichever is first. However, the application could be tentatively approved." <P> In other words, 'The FDA cannot approve a patented drug. However, it could be tentatively approved.' <P> http://www.fda.gov/oc/initiatives/hiv/default.htm <P> What did the US really announce? That it has developed system, with brand new but undefined requirements of applicants. The new process does not exist yet -- and it will take time to establish a new layer of bureaucracy and obligation for generic manufacturers. The Bush Admin is being applauded by an under critical public for overtly creating new obstacles to generic competition. <P> The U.S. has timed its announcement so that major drug companies can simultaneously announce their intention to develop combined blister packs and combination products, suggesting that the program is designed largely to expedite approval of U.S. products trying to catch up with superior fixed-dose combination generic ARVs already approved by the stringent WHO Pre-qualification Project. Rather than join the existing multilateral process as the WHO, however, the U.S. is insisting on a go-it-alone process adding a unnecessary parallel system that for all intents and purposes will merely duplicate WHO approvals made six to twelve months ago. <P> The U.S. has also timed its announcement on the eve of the World Health Assembly where it expected to receive enormous criticism from activists and developing countries anxious to continue and expand the procurement of generic FDCs two to four times cheaper than the most highly discounted brand name drugs. <P> Summary points: <ul> <li> The new process will be lengthy and is designed to delay and discourage generic manufacturers by erecting extensive new barriers relating to manufacturing and bioequivalence</li> <li> The new process does not exist yet, and the criteria are opaque.</li> <li> The new process is a slap to the world communities' internationally recognized drug quality standards. The new process duplicates and sabotages an already functioning process at the WHO's Drug Prequalification program.</li> <li> While this shakes out before the two-to-six-week clock is ever initiated, countries and recipients will be locked into supply chain management, procurement systems, and contracts with big pharma drugs. (Note: even though the "Draft Guidance" released today is open for 60 days of comment, HHS indicates it is effective immediately. But a manufacturer would likely to be hesitant to respond to guidelines that are still apparently in draft form, even if they are "effective immediately.")</li> <li> FDA's Draft Guidance indicates they will consider completing Good Manufacturing Practice inspections even before an NDA is submitted, in order to save time. This is particularly important for companies that have no existing relationship with the FDA. The FDA must aggressively inform generic companies that this opportunity exists.</li> </ul> <P> The go-it-alone process is worthless delay, and a wasteful duplication of a system that is already working. The Bush Administration's goal has long been to obfuscate and delay generics until they have locked in countries and PEPFAR recipients to branded drugs. Other than meeting that goal, the HHS process is entirely unnecessary and duplicative of the WHO Prequalification Program. <P> The US is buying time, appearing to be finally finding religion on this issue, when what they are really doing is making a bit of space for the release of co packaged ARVs from big pharma. This will come at the expense of access to low cost, already quality assured FDCs. And co packaged drugs are still dramatically more expensive and complex than single pill generic FDCs. <P> The Bush Administration is disregarding internationally recognized standards, and pretending to fix a system that is not broken. The WHO's Prequalification program is sufficiently rigorous, already supports high standards, and has already amassed a collection of bioavailability and other important data about generic FDCs and the companies that manufacture those and other medicines. The US appears to be making the absurd request of these companies that they start over, and recreate those human studies according to FDA's standards. This will waste time and money. Furthermore, these standards are likely be unnecessarily arbitrary in a manner that disqualifies generic products on non substantive matters. <P> Creating a new parallel system with different requirements of manufacturers and processes for drug approval and different standards for GMP undermines WHO prequalification. It will waste time and create confusion. It is unnecessary. Quality assured generic FDCs exist now, under internationally recognized standards established by the international agency that sets public health norms. <P> WHO's prequalification project should be supported, not undermined by parallel, conflicting processes. <P> QUESTIONS TO CONSIDER: <P> 1) Is the FDA's Good Manufacturing Practices criteria different from WHO's GMP? <P> 2) Will the FDA determine new and different bioequivalence standards from the WHO -- requiring time consuming new tests to be performed and submitted? <P> 3) What's the real time line for approving generic FDCs given data submissions, plant inspections, and regulatory approval? <P> 4) Will the U.S. data exclusivity rules preclude purchase of the newest life-saving medicines and of generic copies of proprietary fixed-dose combinations? What rationale is there for this monopoly? <P> 5) Will the U.S. require post-surveillance measures for drugs that it will not yet authorized for sale in the U.S.? <P> 6) Why didn't the U.S. plan for this contingency 12 months sooner and why has it take so long to communicate this option to generic producers? <P> 7) What are the real costs going to be for generic producers? Given the desirability of minimizing final cost of products and of spurring development of FDCs, why not announce a blanket waiver of such fees? <P> 8) US money pays for generic drugs that are WHO prequalified now. Why stop? <P> In the months it takes for this useless and duplicative process to be developed -- and in the ensuing months thereafter when the companies are made to jump through hoop after hoop -- the recipients -- and countries -- will already be locked into supply chains and procurement systems and contracts with big pharma. AND branded pharmas will crow about taping a few pills to a package -- more expensive, more difficult to take pills. This announcement is simply announcing that the US will create a window for big pharma to fill market space before the generic medications can even be approved. <P> If the US were truly concerned that FDCs pre qualified by WHO were not "of quality," it would prevent its money from being used for ARV treatment programs by the Global Fund immediately. It would stop USAID from circumventing the "buy America" policy that has been circumvented since Barcelona in 2002. The US knows that WHO standards are acceptable--there is no need for a brand new process. It appears that the real reasons that the US refuses to use the WHO pre-qualification project are not related to ensuring quality and safety, but rather to do with protecting brand name pharmaceutical company interests. <P> The US does not want its imprimatur on low cost generic, quality assured FDCs. Should the rest of the world be made to bow to the US to accommodate this ideological position? <P> The new system of approval by HHS is an excessive new barrier against generic drug makers. <P> A more critical eye in the media is encouraged. <P><P ALIGN="CENTER"> #30# </P> <br><a href=#top>Back to Top</a><br> </BODY> </HTML>