Access To Medicines Project

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.
-----

The Eshoo-Barton-Inslee and Hatch-Enzi-Hagan Approach to Biogenerics:
Evergreening and the Creation of Perpetual Monopolies

Congress is now considering proposals to establish a process for regulatory approval of generic versions of biotech medicines ("biologics"). Proposals passed by the Senate health committee and sponsored by Representatives Eshoo, Barton and Inslee, however, would establish prolonged delays before permitting price-lowering generic competition.

The HELP (Senate Health, Education, Labor and Pensions Committee) and Eshoo-Barton proposals would establish a 12-year marketing monopoly (known as “data exclusivity”) for brand-name biologics, a monopoly that is separate and distinct from the patent monopoly. During this period, generic competitors would be prohibited from relying on the safety and efficacy tests conducted by brand-name companies, effectively preventing them from coming to market. This excessively long period of monopoly protection (conventional drug makers get only five years) has no correlation with biologics' manufacturing or research and development (R&D) costs.

Even more worrisome, the HELP and Eshoo-Barton proposals would permit brand-name companies to pursue "evergreening" strategies that would enable them to obtain sequential 12-year marketing monopolies on biologics. The effect would be to prevent price-lowering generic competition for decades and to torpedo the objective of cost containment, which is central to current healthcare reform efforts.

You can read the remainder of the fact sheet in the continuation of this post, or download a copy below.

Click here to dowload the .pdf version of a fact sheet on this topic: BiogenericsEvergreeningJuly2009.pdf

Click here to download a .rtf version of a fact sheet on this topic: BiogenericsEvergreeningJuly2009.rtf
-----

Washington Post Editorial

WITH A NAME like the Affordable Health Choices Act, you'd think the health-care reform bill that passed the Senate Health, Education, Labor and Pensions Committee this month would have made an effort to provide affordable health choices. But instead, the bill includes a provision that would create a 12-year market exclusivity period for brand-name biologic drugs. This would drive costs to consumers above even current levels, making the title little more than a mockery.
-----

By Liza Porteus Viana
Intellectual Property Watch

As the United States Congress prepares to recess in early August, there’s hope - and dread, depending on which “side” of the debate you’re on - that legislation creating a regulatory pathway for follow-on biologics may be pushed through as part of the broader healthcare reform package.

The biologics debate centres on how to bring “biosimilars”- as close to generic versions as possible - of complex, living, and expensive biologic drugs to market so cheaper versions are available for consumers. These drugs have the potential to treat debilitating diseases like cancer, Multiple Sclerosis and Alzheimer’s. Brand-name drug companies, which are producing the bulk of these products, spend billions of dollars and many research hours producing biologics, and they want to protect their research and product as long as possible before generic companies can try to replicate the drugs in order to gain as much profit as possible.

But generics companies, consumer groups and others say this is another attempt by the big brand-name pharmaceutical companies to monopolise the market and prevent people from being able to access cheaper medicines. According to the Federal Trade Commission, in 2007, Americans spent $286.5 billion for prescription drugs; $40.3 billion of which was for biologics.

“Sadly, the Congress is seriously considering legislation that would undermine the best chance we have to provide a market-based approach to moderate the cost growth in the most rapidly inflating, highest-cost element of the pharmaceutical industry - biotech drug products,” said Kathleen Jager, president of the Generic Pharmaceutical Association (GPhA).
-----

Sarah Rimmington and Robert Weissman
The Roanoke Times

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 an amendment to the health care legislation that will cost consumers and the government tens of billions of dollars? And will Rep. Rick Boucher, who holds a key position on the relevant House committee, vote 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 marketplace competition?

Big Pharma is today salivating at the prospect of hijacking the health care reform process to enhance its ability to price-gouge the American public.

As the House Energy and Commerce Committee meets to vote on health care legislation, it is expected to consider an amendment from Reps. Anna Eshoo of California, Joe Barton of Texas and Jay Inslee of Washington state -- supported by Big Pharma and the biotech industry -- to authorize generic competition for biotech drugs. Currently, there is no regulatory process for approval of generic versions of this class of pharmaceuticals, known as "biologics."

Biologics make up roughly half of the most important new medicines. Important biologics include many or most new cancer drugs, drugs for the treatment of severe arthritis and psoriasis, multiple sclerosis and numerous vaccines.

Biologic drugs are the fastest-growing segment of the pharmaceutical market, and they are priced significantly higher on average than brand-name conventional drugs. For example, the top-selling biologic, Enbrel, Pfizer/Amgen's arthritis treatment, costs $15,000 to $20,000 per patient per year. Roche/Genentech's cancer drug Avastin costs approximately $185,000 per year.

These extraordinary prices do not reflect high manufacturing or research and development costs. Shielded from competition, brand-name companies charge so much simply because they can.
-----

The U.S., E.U., and key trading partners are negotiating an Anti-Counterfeiting Trade Agreement (ACTA). ACTA is one of several major new initiatives seeking, in part, to protect drug monopolies under the guise of fighting counterfeits. Much like a counterfeit, ACTA misrepresents its true ingredients to the public.

In a new fact sheet, Essential Action outlines some key concerns ACTA may pose, focusing on access to medicines. Then we recommend basic principles the United States and other countries should follow if they decide to continue participating in ACTA negotiations.

The concerns outlined in the fact sheet are:
- ACTA will keep medicine prices high
- ACTA threatens the generics industry
- ACTA fails to adequately address public health & safety concerns
- ACTA’s draft text is secret
- ACTA enforces private monopolies at public cost

Download a .pdf version of the fact sheet here: ACTAFactsheet.pdf
Download a .doc version of the fact sheet here: ACTAFactsheet.doc

By Sarah Rimmington and Robert Weissman
Special to the San Jose (Silicon Valley) Mercury News

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 then is that same Congress on the verge of adopting an amendment to the health care legislation that will cost consumers and the government tens of billions of dollars? And will Rep. Jerry McNerney, D-Pleasanton, who holds a key position on the crucial House committee, vote to support a giant giveaway to Big Pharma and the biotech industry? Or will he support common-sense measures to control costs and foster competition?