Access To Medicines Project

Pharma Times
By Lynne Taylor

US campaigners yesterday urged Congress to create a “real” regulatory pathway for generic versions of biologic drugs, but researchers warn that it may take until 2011 to implement any such policies.

Current proposals for a regulatory pathway for generic biologics - also known as biosimilars, biogenerics or follow-on biologics - in Senate and House healthcare reform bills will actually block production of most generic biologics, but if these are improved in critical ways they could save $71 billion or more in the first decade alone, say the consumer and medical student groups which are leading the campaign.

The proposals, originating from Representative Anna Eshoo House bill HS 1548 and past bills in the Senate, would provide 12 years’ market exclusivity for biosimilars compared to five years for other drugs. However, the campaigners point out, the Pharmaceutical Research and Manufacturers of America (PhRMA) puts development costs for biologics at $1.2 billion, close to that for conventional drugs at $1.318 billion, and that the Federal Trade Commission (FTC) recommends zero years market or data exclusivity for biologics, given that biosimilars will cost more to bring to market for generic manufacturers than conventional generics, leaving originator companies with 70%-90% of the market.

These proposals will also allow “evergreening,” whereby pharmaceutical companies will be allowed additional 12-year periods of exclusivity for “relatively inexpensive minor tweaks” which, they say, could block price-lowering generic competition indefinitely.

The language in these bills creates biologic drug monopolies, which discourage innovation and raise costs for the US health system, say the campaigners. However, they add that these problems can be addressed by adopted the relevant sections of bills introduced by Representative Henry Waxman (HR 1427) and Senator Charles Schumer (S 726), which would allow five years’ exclusivity and block evergreening.

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Healthcare Reform Offers Only the Illusion of Generic Competition for Biotech Drugs: Patient Access To Expensive New Medicines at Stake

U.S. Congress is considering proposals to establish a process for regulatory approval of generic versions of biotech drugs ("biologics"). The Food and Drug Administration (FDA) approval process available for conventional pharmaceuticals does not apply to biologics, which are drugs engineered from human or animal cells using biotechnology. New and different procedures are required to demonstrate the safety and efficacy of comparable and interchangeable biologic pharmaceuticals (called “biosimilars” or “biogenerics”).

Proposals passed by the Senate and House health committees as part of healthcare reform in July 2009, however, will establish prolonged delays before permitting price-lowering generic competition. Even worse, they will facilitate brand-name companies’ ability to renew their monopolies, potentially keeping generic firms out of the market for biologics altogether and creating only the illusion of generic competition. Either result will torpedo the objective of healthcare cost containment so crucial to current reform efforts, and severely limit patient access to these important and exceptionally high-priced medicines for conditions like cancer, arthritis and diabetes.

The bottom line is this: Under these proposals, Medicare and other federal programs will find their budgets increasingly strained by growing biologic drug costs. Employers will continue to struggle to provide affordable health insurance to their employees. Americans with insurance will find it even more difficult to pay for their already sky-high prescription drug co-payments. And the uninsured may have to go without crucial lifesaving biologics.

For more information, download the .pdf version of the briefing note here: BiologicsBriefingNote28_Sept_09.pdf

Download a .rtf version of the briefing note here: BiologicsBriefingNote28_Sept_09.rtf

For more details about one of the most pressing issues in these proposals, the creation of almost indefinite monopolies through the evergreening of the data exclusivity monopoly, please see the fact sheet available here.

FOR IMMEDIATE RELEASE
September 28, 2009

Contact: Sara Crager, MD PhD, Yale University, and member, Universities Allied for Essential Medicines (UAEM)
Phone: (203) 444-4805 Email: sara.crager@yale.edu

Contact: Ethan Guillen, Director, Universities Allied for Essential Medicines (UAEM)
Phone: (775) 287-2553 Email: ethan.guillen@essentialmedicine.org**


CURRENT PROPOSALS IN HEALTHCARE REFORM BILLS WILL BLOCK MOST GENERIC BIOLOGICS

Student and consumer groups, Universities Allied for Essential Medicines (UAEM) and the American Medical Student Association (AMSA), supported by consumer groups Essential Action and Knowledge Ecology International, are today calling on Congress to create a real pathway for the production of generic biologics. Current proposals for generic biologics or “follow-on biologics” in Senate and House versions of healthcare reform legislation that purport to create such a pathway will actually block production of most generic biologics, which -- if the current proposals are improved in critical ways -- could save $71 billion or more in the first decade alone.

The organizations involved support healthcare reform now, but urge Congress to fix this serious challenge to future affordable access, both here and abroad, which could also create tremendous savings for the healthcare system.

To engage and educate consumers and patients from across the United States
in the fight for affordable medicines, UAEM and AMSA have launched a website, http://www.AffordableMedsNOW.org

Comunicación Positiva, a Colombian NGO that develops communication strategies for civic engagement and human rights, has produced a series of documentary audio programs and a video short covering the evolution of the HIV/AIDS compulsory license & access to medicines campaign in Colombia, 2008-2009. The Spanish-language series is entitled "For the right to health – no to patents!" ("Por el derecho a la salud – no a las patentes!"), and features interviews with about thirty activists, analysts and people living with HIV/AIDS.

Check out the video introduction (in spanish) on Youtube here.

To download a zip file (higher-resolution version also in spanish), click here.

To listen to the audio series (in spanish), visit this site.

The audio series (in spanish) is also available on CD from Comunicación Positiva. Contact: David Morales; david.morales.alba@gmail.com

Bogotá, Colombia – Wednesday, September 16, 2009 –

Today, NGOs, attorneys and activists filed suit in Colombian court to compel the government to authorize price-lowering generic competition with Abbott Laboratories' costly HIV/AIDS treatment Kaletra (lopinavir+ritonavir, LPV/r).

The "acción popular" demands an open compulsory license allowing any producer that can demonstrate drug safety and efficacy and good manufacturing practices to use patented technology to bring generic LPV/r to market.

Chicago-based Abbott enjoys a LPV/r monopoly in Colombia, where Kaletra, a key second-line HIV/AIDS medicine, ranks consistently among the health system's most expensive annual medicine purchases and routinely sells for well over $3,000 per person per year. Global competitive prices have dropped under $500. Earlier this year, in response to Colombian NGOS administrative request for a compulsory license, the Colombian government imposed price ceilings on the drug – approximately $1,000 for public sector sales and $1,600 for the private sector. But recent reports suggest Abbott has violated the price order in its transactions with at least some purchasers. The National Commission on Medicine Prices is investigating.

The eighty-page acción popular cites state failures to provide for Constitutional and collective rights to health. It names the health ministry, patent office, drug regulatory authority and Abbott Laboratories as defendants. Plaintiffs include Fundación IFARMA, Fundación Misión Salud, RECOLVIH (Colombian network of people living with HIV/AIDS), and attorneys Luz Marina Umbasía (in her personal capacity), Giomar Angélica Aguilar and Germán Rincón Perfetti.

We will occasionaly issue updates on the suit's progress and also hope provide more information soon. With questions, English speakers can contact Peter Maybarduk at Essential Action (peter.maybarduk@essentialinformation.org) or Francisco Rossi of the Colombian Foundation IFARMA, a plaintiff in the suit (francisco_rossi@hotmail.com).

Earlier this year, Colombian HIV/AIDS groups won major price reductions for the antiretroviral drug lopinavir + ritonavir (Abbott Laboratories' Kaletra) through a compulsory license campaign. While the Colombian health ministry eventually turned down the license request "for now", the campaign moved the government to fix a price ceiling for Kaletra, some 54-68% lower than Abbott's previous prices. The price ceiling should reduce the average annual treatment cost per person by about $2,000 per year.

Nevertheless, reports are surfacing that Chicago-based Abbott may be defying the price order in its sales to some buyers. The National Medicines Pricing Commission (Cnpm), which imposed the ceiling, is investigating. An article this week in El Tiempo , Colombia's largest newspaper, quoted an anonymous knowledgeable source in Colombia's largest healthcare providers association, saying Abbott's prices have not changed. (Officially, the association reported it could not disclose the prices it pays Abbott, due to a confidentiality agreement.) And receipts from a separate source show at least one consumer recently paid prices considerably higher than the ceiling.

Although Abbott has not commented on the reports, it has petitioned the government to revoke the price order.

Health Minister Diego Palacio sent healthcare providers a letter last week concerning lopinavir+ritonavir's new price, saying the state "will prevent any person or company from abusing their dominant position in the market." If the Pricing Commission's investigation reveals Abbott has failed to comply with the price order, it will refer the case to the Agency for Industry and Competition (SIC) to levy sanctions.

Notably, Abbott's refusal to comply with the price order would provide Colombia new and persuasive legal grounds to issue a compulsory license: precisely the anti-competitive conduct cited by Minister Palacio in his letter. In order to maintain credibility and preserve its authority, the Colombian government needs to take swift and stern action. Colombian HIV/AIDS groups will make the case.

The El Tiempo article is available in Spanish in the continuation of this post.
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The Tennessean (Nashville)
By Sarah Rimmington and Robert Weissman

Other Views

As Congress considers health-care reform, many members are suggesting that reform must be tempered in light of the potential expense of expanding coverage. Why in the world, then, is that same Congress on the verge of adopting health-care legislation that includes prescription drug proposals that will cost consumers and the government tens of billions of dollars?

And will U.S. Rep. Bart Gordon, D-Murfreesboro, continue to support a giveaway worth tens of billions of dollars to Big Pharma and the biotech industry, or will he support common-sense measures to control drug costs and foster market competition?

Earlier this summer, House and Senate committees approved a Big Pharma-backed approach for FDA approval of generic versions of "biologic" drugs. Gordon voted for the Big Pharma- and biotech industry-favored proposal. A more balanced approach supported by all the consumer groups involved in the issue would have facilitated expedited price-lowering generic competition.

Biologics are the fastest-growing segment of the drug market and are priced 22 times higher on average than brand-name conventional drugs. In some cases, prices approach or exceed $100,000 per patient per year. Roche/Genentech's cancer drug Avastin costs about $185,000 per year.

Unfortunately, rather than creating robust price-lowering competition, the approach now included in the health bills would establish extended protections — exceeding the monopolies already conferred by patents. These might keep generic firms out of the market for biologics altogether, costing U.S. consumers additional tens of billions of dollars.

To The Editors:
Re: Our view on generic medications: Drugmakers seek excessive monopolies on ‘biologics’ (USA Today Editorial Board, August 12, 2009)

I couldn’t agree more that healthcare reform proposals currently give Big Pharma and Biotech “excessive” 12-year marketing monopolies for over-priced biologic pharmaceuticals that will allow drugmakers to price gouge American patients for far too long.

Even more worrisome, the plans will enable manufacturers to make relatively cheap and easy tweaks to old biologics and gain an additional 12 years of monopoly protection. This will further delay price-lowering generic competition for biologics like Roche-Genentech’s $185,000 per year blockbuster cancer treatment Avastin. These simple changes include creating a once-a-day pill where the original was a thrice-a-day product, or replacing a shot with an inhalant or pill.

While these tweaks might offer benefits, their cost will often be only a small fraction of what companies spend developing a new product. Pharma does not need the lure of additional monopolies to make minor changes.

The bottom line is that in most cases this approach will offer only the illusion of generic competition and will torpedo the objective of healthcare cost containment. That’s hardly smart. And it’s definitely not fair to American consumers, insurers and taxpayers.

We must demand that Congress and President Obama eliminate this unjustified windfall for Big Pharma.

Sarah Rimmington
Attorney, Essential Action
Washington, DC

FOR IMMEDIATE RELEASE

Following are comments from consumer, public health and student groups, state legislators and experts following today’s House Energy & Commerce Committee vote to add the Eshoo-Barton-Inslee generic biologics (biogenerics or biosimilars) amendment to America’s Affordable Health Choices Act of 2009.

Sarah Rimmington, Attorney, Essential Action, Access to Medicines Project, Tel: (202) 387-8030 or Cell: (202) 422-2687, srimmington@essentialinformation.org
"The biogenerics proposal adopted today torpedoes the objective of health care cost containment. The Eshoo proposal only offers the illusion of price-lowering generic competition for biotech drugs like Roche-Genentech’s $72,000 per year cancer treatment Herceptin. By making cheap and easy tweaks to old biologic drugs, Big Pharma will be able to obtain near perpetual monopolies and keep affordable biogenerics from pharmacy shelves several decades after their patents expire.

It’s hard not to wonder if the $1 million per day Big Pharma and Biotech spends lobbying influenced today’s vote.

But it’s not too late. Congress can stop Pharma from continuing to price gouge the American public by fixing the biogenerics proposals on the floor of the House and Senate. President Obama can demand changes before signing a health care bill into law We can’t afford for them not to."


Larry McNeely, Health Care Advocate, US PIRG (Public Interest Research Group), (202) 546-9707 x 303, lmcneely@pirg.org
“The biologics measures passed today are nothing more than a bailout for Biotech and Pharma.”


Joana Ramos, MSW , Director, Washington Coalition for Prescribing Integrity and cancer survivor, Seattle, WA (206) 229-2420, jdr@ramoslink.info
“Patient and their families need relief from the exorbitant, and ever-escalating prices, being charged for biologic medicines. Medical innovations are of no value without access. Limiting the period of marketing exclusivity to 5-7 years for these new drugs is an important first step to solving the problem.

Almost every week my colleagues and I work with, or seek help for, not only the uninsured, but increasingly also insured patients facing food insecurity, evictions, foreclosures on their mortgages, bankruptcy, and even relapse and untimely death just because of the price of biologic drugs. In one recent case, an insured college student with rheumatoid arthritis had a flare-up so severe that he had to be hospitalized, after his 6-month co-pay grant for Kineret from an assistance program ended. Because it took several more months for him to be able to get into a new program, his parents, members of the squeezed middle class, then had to put the monthly co-pays of $650 for Kineret on their credit card during the wait. They now struggle with that debt plus the close to $10,000 of the "patient responsibility" portion of the hospital bills, plus insurance premiums that have almost doubled since 2006. Patients with RA are thought to need these drugs for the rest of their lives.

Compared to many biologic cancer drugs however, Kineret is a "bargain," at some $1400/month. Drugs like Herceptin and Tykerb run in the multiple thousands of dollars per month, and 4-figure co-pays are common.”

We are deeply disappointed by the decision of the House Committee on Energy and Commerce to adopt the BIO and PhRMA-backed amendment on generic biologics. Instead of opening the door to less expensive generic drugs and the potential for enormous savings to patients and healthcare providers, including federal and state governments, this amendment will insure that BIO and PhRMA companies can charge monopoly prices for a minimum of 12 years. The proposal that passed today will also make it much easier for brand companies to wait until the eleventh hour to make minor changes to old biologics, and then renew the 12 year marketing monopoly an unlimited number of times.

Neither the brand industry nor the supporters of the amendment have ever credibly explained why the manufacturers of brand biologics should be entitled to a guaranteed 12 years of exclusivity, which is in effect 12 years of monopoly prices, when the patent system has been adequate to protect innovation in every other industry. They have also never explained why 12 years of exclusivity is appropriate for the manufacturers of biologics, when since 1984 the manufacturers of chemical drugs have thrived with five years of exclusivity.

We are also disappointed that the majority of the Committee ignored the recent study of the Federal Trade Commission, which concluded (1) that there is no basis for granting biologics manufacturers 12 years of exclusivity and (2) that there is no evidence that their patents are weaker than the patents on chemical drugs. There are many competing studies on this subject, but the FTC is independent and unbiased and has deep expertise in laws pertaining to patents and competition.

We can only conclude that the Committee’s action reflects the continuing influence and power of Big Pharma, which has made adoption of the Eshoo-Barton amendment a high priority. We pledge to fight on the floor of the House and Senate and in every other forum that is available for a viable generic biologic program which will allow the Food and Drug Administration to approve generic biologics once valid patents have expired. If meaningful changes cannot be made, then we urge Congress to drop the generic biologics amendment from healthcare reform legislation.
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