22 Sep

Republican Rep McCotter, Our Pharmaceutical Rep In Congress

McCotter, Republican Representative from the 11th Michigan District, was paid off with this pamphlet from the Pharmaceutical Industry that circulated thru the district. The good news is that his bill died an early death.

The Gene Association (GPhA) released the following statement today from GPhA President and CEO Kathleen Jaeger regarding the introduction of H.R. 1548, “The Pathway for Biosimilars Act.”

“The Pathway for Biosimilars Act is the wrong road for patients looking for safe and affordable biogeneric medicines, particularly during these difficult economic times. It is a long route filled with needless roadblocks that will keep patients from getting needed medicines in a timely manner.

“To increase competition and ensure timely patient access, Congress needs to enact a workable pathway without unnecessary barriers. The bipartisan consensus bill, the Promoting Innovation and Access to Lifesaving Medicine Act, introduced last week achieves the balance of fostering pharmaceutical innovation while also making affordable medicines available to consumers. This bipartisan bill recognizes our health care system’s successful experience with generic medicines for the past 25 years. The market exclusivity provisions in Hatch-Waxman have clearly demonstrated that we can achieve the much-needed balance between pharmaceutical competition and innovation for the benefit of consumers, payors and state and federal governments.

“That’s why consumer, business and labor organizations, AARP and many of our nation’s governors support the Promoting Innovation and Access to Lifesaving Medicine Act that brings biogeneric medicines to consumers sooner rather than later through timely resolution of patent disputes and market exclusivity provisions consistent with the Hatch-Waxman model.

“Unfortunately, The Pathway for Biosimilars Act is the wrong medicine for patients and our nation’s health care system. This bill will only benefit brand companies by erecting barriers including an unprecedented and unjustifiable 14 years of market exclusivity. Given that there is a minimal difference of less than eight months longer in the development of biopharmaceuticals when compared to traditional pharmaceuticals, there is little justification for excessively expanding exclusivity beyond the Hatch-Waxman model. Excessive exclusivity means that it will be decades before patients have access to affordable biogeneric medicines. For the countless patients who are choosing between paying for their medicines and putting food on their tables, waiting decades is simply not an option.

“Timely access to affordable biogenerics will save lives and save consumers and state and federal governments billions of dollars. The time has come for a truly workable pathway, not a pathway in name only.”

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk active pharmaceutical chemicals, and suppliers of other goods and services to the generic drug industry. Generics represent 69% of the total prescriptions dispensed in the United States, but only 16% of all dollars spent on prescription drugs. For more information about the industry, visit


Knowledge Ecology International (KEI) opposes H.R.1548, the bill to “establish a pathway for the licensure of biosimilar biological products,” on the grounds that the period of the monopoly is excessive, and not subject to safeguards that would protect consumers.

HR 1548 conditions market entry for biosimilar products on a 12 to 14.5 year period of legal monopoly for products that is independent of the patent status of products. The putative rationale is to reward investments in new products. However, there is no requirement that the monopoly bear any relationship to the investments in particular products, pricing, or the cumulative revenues generated by the product. The period of exclusivity can extend 9 years beyond that currently exists for pharmaceutical drugs, and presents considerable risks to the public as consumers, taxpayers, employers and subjects of medical experimentation.

The alternative approach supported by Representative Waxman and the White House of providing a 5 to 7 year monopoly is also excessive, but certainly preferred to an approach that provides a 14.5 year monopoly.

KEI agrees with Essential Action and others that believe a bill based upon exclusive rights to rely upon safety and efficacy of products is itself fundamentally flawed, for several reasons, including the fact that it provides economic incentives for unnecessary and unethical clinical testing of products on human subjects. KEI encourages members of Congress to reflect on the provisions of the Declaration of Helsinki on the ethical principles for medical research involving human subjects, including but not limited to Articles 20 and 21, and to consider if other approaches are more appropriate, including those that allow biosimiliars to enter into agreements to share the risk adjusted costs of clinical trials./1/

In any case, the grant of a monopoly should not be without limits or safeguards to protect consumers and taxpayers. Any bill that grants a legal monopoly from competition should also include provisions that allow the monopoly to be eliminated if products are priced excessively, or if other factors merit a review of the monopoly status. The bill should also require that companies disclose actual R&D costs, prices and revenues for products, and that that the federal government should have the opportunity to review the provision periodically to determine if the term of the monopoly is excessive, or if there is a need for additional safeguards to protect the public, or if new approaches, such as cost sharing, are more appropriate in the context of a policy to advance health interests.

Knowledge Ecology International

*Knowledge Ecology International (KEI) is a non-profit organization that focuses on issues about innovation and access to knowledge goods, including new medical inventions.

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