American prescriptions fees set to rise by six per cent

Times have been tough of late for blockbuster pharmaceutical companies in the US. Firstly they face losing patents on their top-selling drugs to generic drug manufacturers. They have also recently agreed to hand over an extra six per cent to the US Food and Drug Administration (FDA) for the approval of new prescription drugs.

The rise will mean that firms gain the approval of standard prescription drugs quicker and also drugs earmarked as a priority. The decision comes about following lengthy negotiations between the brand-name drug industry and the FDA and has resulted in the publishing of a draft letter, which sets out the new, revised goals of the Prescription Drug Fee User Act (PDUFA).
 
Negotiations were authorized because the former PDUFA act is set to expire on September 30th and the new legislation still need to be rubber stamped by Congress before that date.
 
The drafted plans would, if finalized, add a massive $40.4 million to the agency's revenues from fees, bringing the total for the financial year 2013 to $712.8 million. However, this isn't just administrative fees that the huge pharmaceutical industry hands over freely. This money will have to be made up elsewhere on the medical chain, namely the consumers and users of such drugs. However, it doesn’t seem to have caused much concern within the two bodies that members of the public will see prescription prices rise.
 
According to the Pharma Times, Dr Janet Woodcock, director of the FDA's Centre for Drug Evaluation and Research, said: "this agreement will continue the review program that allows those products to move expeditiously through the regulatory process so they can reach the public in a timely way."
 
This is a novel way of looking at the situation. In short, the agreement will mean drugs can get through the system quicker so it's a small price to pay.
The new bill also lays out rules for the establishment of a reviewing system aimed new molecular entities. This, the bill claims, will aim to improve efficiency and safety assessments within the very first review stage. Increased scientific communication and transparency between manufacturers and officials throughout the remainder of the review process will then ensure a better way of testing and screening drugs.
The draft also included proposals for greater standardisation and earlier consideration of risk evaluation and mitigations strategies (REMS) in the review process, enhancing agency programmes for post-marketing surveillance and adverse events tracking, and making new resources available to modernise regulatory science and enable the FDA to conduct outreach to patients, in order to better understand their views on disease severity and unmet medical need.
This was echoed in a statement released by the Pharmaceutical Research and Manufacturers of America (PhRMA), where its senior vice president for scientific and regulatory affairs, Dr David E Wheadon, said: "FDA’s robust drug safety system would also be strengthened through provisions in the agreement that include greater standardization of and earlier consideration of risk evaluation and mitigation strategies (REMS) in the review process."
 
The Biotechnology Industry Organization's chief executive Jim Greenwood said: "We urge Congress to support FDA's mission and fund the agency at the Administration's FY2012 requested levels."
 
So it seems that you can put a price on your health and for Americans it has just risen six per cent. Such is the way of the world and at least now, according to industry bodies anyway, drugs will be reviewed and accepted much quicker and much more efficiently.

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