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Healthy Skepticism Library item: 19124

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: news

Grogan K
PhRMA blasts Obama over pay-for-delay ban plan
Pharma Times 2011 Feb 15
http://www.pharmatimes.com/Article/11-02-15/PhRMA_blasts_Obama_over_pay-for-delay_ban_plan.aspx


Full text:

Innovation-based drugmakers have told President Obama in no uncertain they are not impressed by his 2012 budget proposals, especially plans to reduce patent protection on biologics and end ‘pay-for-delay’ deals with generics firms.

The White House budget, designed to cut some $1.1 trillion from the US deficit over the next decade, contains a couple of proposals directly affecting the pharmaceutical industry. First up is a plan to cut marketing exclusivity for brand-name biologics to seven years from 12, while the second would give the US Federal Trade Commission power to block controversial agreements between pharma and generic drugmakers which see the latter receive payments in return for delaying launches of their versions of branded medicines.

The White House believes the two proposals would save about $11 billion over 10 years, with most of that saving, some $8.8 billion, coming from a ‘pay-and-delay’ ban. The welcome from big pharma has not been warm, however.

Related Links
US Senators and states act against generics deals
US pharma fury over new moves to ban pay-for-delay deals
Victory for pharma as bill keeps biogeneric pathway blocked
Incentives for R&D reduced

The head of the Pharmaceutical Research and Manufacturers of America, John Castellani, said the President’s budget proposal “would diminish crucial incentives for future US medical innovations”. He claimed that the 12-year biosimilars provision of the healthcare reform law passed last March, “the only provision in the law to garner strong bipartisan support, achieves an essential balance. It provides appropriate incentives to support future medical advances”.

Mr Castellani went on to say that “such a public policy flies in the face of the Administration’s recent commitments supporting domestic innovation, biomedical research, jobs and US competitiveness”. He added that if passed, the proposal would provide “less data protection for new, innovative biologics than is currently bestowed in Europe”.

The PhRMA chief went on to say that “patent settlements are a vital aspect of a patent owner’s ability to protect intellectual property“and restricting such settlements, “which already are subject to review by the Federal Trade Commission and the Department of Justice”. Without settlements, “innovators’ defence of their patents in court could keep generics from being available to patients for years”.

Mr Castellani said that “while we understand the need to reduce the deficit, policies such as these represent the wrong approach. Instead, our country needs to retain and extend policies that promote the growth of private-sector R&D investment and secure our sector’s future”. He ended by saying that “while the USA currently retains an advantage in medical innovation, it’s ours to lose”.

Flawed approach

The Generic Pharmaceutical Association said it was concerned at the proposal to ban patent settlements, “a misguided public health policy initiative that has repeatedly failed to receive Congressional support in separate and frequent legislative attempts at passage”. As for the claim that such a ban would save $8.8 billion, GPhA believes “that this economic assumption is fatally flawed”.

The association went on to say the FTC already has the authority to review and reject any patent settlement “and that its challenges to the validity of settlements has been consistently and soundly rejected by the courts”. It added that these settlements “have never prevented competition beyond the patent expiry, and generally have resulted in the early, date-certain introduction of generics years earlier than would otherwise have been possible”.

The GPhA argues that “Congress should reject this initiative, and instead concentrate efforts on those initiatives that would continue to dramatically reduce prescription drug spending”. These would involve promoting “the increased utilisation of generics for federal and state government funded health care programmes and accelerating the approval of more affordable generics by increasing funding for the Office of Generic Drugs”.

However, the GPhA backed Obama’s plan to reduce exclusivity period for branded biologics be reduced to seven years. It said “there is no question that a 12-year exclusivity period would provide unwarranted monopolies for brand biopharmaceuticals, which would delay the savings that could result from the earlier introduction of biogenerics”.

 

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Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909