On Friday, the House Committee on Energy and Commerce adopted a proposal for biosimilars that provides an excessive period of monopoly while allowing vast loopholes which could allow evergreening – ie under the proposal, companies could potentially restart the monopoly period for minor tweaks to the medicine.
Read a joint statement from consumer and health advocates along with individual quotes below.
Statement of Consumer Groups Regarding Adoption of Industry-Backed Eshoo-Barton Amendment to Health Care Reform Legislation
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.
Dear Senator or Representative,
Congressional consideration of healthcare reform has two overriding goals: expand health coverage to the uninsured, and contain costs. It is widely understood that the first goal cannot be achieved absent success with the second objective.
It is therefore vital that Congress take steps to lower the price of the most expensive drug treatments, rather than aid Big Pharma and the biotech industry’s ability to price gouge consumers and the government. For this reason, we urge you to support the Promoting Innovation and Life Savings Medicines Act, H.R. 1427 and reject attempts to pass other biologics legislation that will leave affordable care out of reach.
Over the past twenty-five years safe and affordable generic drugs have been an important option for patients. However, there is an entire category of medicines – biologics – that have no generic alternatives because the FDA does not have the authority to approve them. Biologics are among the most expensive and most important drugs available to patients today. They account for 25% of all new drug products approved by FDA and cost on average 22 times more than chemical drugs. Big Pharma and the biotech companies charge so much more for biologics not because they are more expensive to manufacture, or because research & development (R&D) costs are higher, but simply because they can. Presently, there is no competition in this critical marketplace.
The Senate HELP Committee and Congresswoman Eshoo have put forward legislation that would grant unprecedented data exclusivity periods to brand manufacturers, which will ensure there is long delayed or perhaps even no generic competition. Both proposals, though very different in many ways, would guarantee brand monopolies for at least 12 years and give brands the ability to extend this monopoly even further. The Federal Trade Commission (FTC) has closely examined this issue and released a study stating that any amount of exclusivity is not necessary to protect this industry. The Administration also opposes lengthy exclusivity periods.
Our nation is experiencing massive healthcare costs during an economic crisis. Increasing the availability of generic biologics will be a critical element of a comprehensive and necessary health care cost containment strategy, and will provide Americans affordable choices in their healthcare. If the wrong legislation passes on this critical issue there will be no generic biologics and patients and a teetering healthcare system will continue to pay the price.
While it is disappointing, it is not surprising that one of the most powerful lobbies in Washington has spent considerable resources to ensure that they retain the ability to charge the highest prices that the market will bear. Consumers and the healthcare system cannot bear these prices any longer. We urge you to oppose generic biologics legislation that contains excessive periods of exclusivity or other unnecessary and significant barriers to generic biologic competition. Don’t let big industry interests trump sound public policy.
Senator John Cornyn
517 Hart Senate Office Bldg.
Washington, DC 20510
Senator Joseph Lieberman
706 Hart Senate Office Bldg.
Washington, DC 20510
The undersigned public interest organizations are writing to express their appreciation for your leadership in sponsoring the 2009 Federal Research Public Access Act (S.1373). This legislation would extend, improve and make more permanent an earlier open access initiative involving NIH funded research.
The new legislation would require that any federal agency with a budget or $100,000 or more for extramural research develop a policy on public access to publicly funded research. Among other things, the legislation would require government funded research papers to be made available in publicly accessible Internet archives within 6 months of publication in a peer reviewed journal, and would ensure the long-term preservation of, and free public access to, the published research finding in a stable digital repository.
The Internet now provides an unprecedented opportunity to amplify and disseminate the results of medical research by making it more widely and easily available than ever before. Improving access to scientific findings will help scientists build on research, accelerating innovation that provides treatments and cures, saving and improving countless lives.
Expanding access to medical research findings is not only important for physicians and scientists but also for patients and their families. Today there are too few medical papers available online including the majority of papers supported with taxpayer funding. Access to these peer-reviewed papers will be of great benefit to doctors and patients in informing treatment decisions.
Access to many scientific papers requires expensive subscriptions and many are never placed online. Congress must ensure that the public, having invested in science, gets access to publicly funded scientific publications and that research findings are easily available to scientists, medical researchers, physicians, students and patients.
As organizations concerned with public health, access to knowledge and a fair return on public investment in the creation of knowledge, we greatly appreciate your efforts on this issue, and encourage your continued diligence in working with the 111th Congress to take the next step and pass this important legislation.
We are pleased to be part of a broad coalition, including hundreds of consumers, academics, librarians, students and many other stakeholders that have expressed their support for the Public Access Act, in order to ensure barrier-free access to taxpayer-funded research (See coalition at: http://www.taxpayeraccess.org/member.html).
If you have questions or would like to discuss this matter further, please contact Knowledge Ecology International at (202) 332 2670.
Knowledge Ecology International (KEI)
Contact: Manon Ress [manon.ress at keionline.org]
IP Justice (IPJ)
Contact: Robin Gross [Robin at ipjustice.org]
Contact: Rob Weissman [rob at essential.org]
Electronic Frontier Foundation (EFF)
Contact: Gwen Hinze [gwen at eff.org]
Universities Allied for Essential Medicines (UAEM)
Contact: Ethan Guillen [ethan.guillen at essentialmedicine.org]
Contact: Rohit Malpani [ rmalpani at OxfamAmerica.org]