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US House set to Pass Medical Funding Bill

29.11.2016 -

The US House of Representatives has scheduled a Nov. 30 vote on a bill aimed at accelerating federal approval of drugs and medical devices as well as boosting biomedical research. The bill, an initial version of which was passed in 2015 by the lower house of Congress, has been stalled for months due to a lack of agreement by political actors punctuated by intensive drug industry lobbying.

US reports said the revised legislation now has good chances of passage in the last session taking place before the end of the year. In particular, the bill known as The 21st Century Cures Act is aimed at streamlining drug safety assessments by federal regulators with an eye to a speedier market launch. In a move long hoped-for by the medical research sector, it would provide fresh funding of $4.8 billion for the National Institutes of Health (NIH) and $500 million to the Food and Drug Administration FDA over ten years.

The latter two pieces of funding especially had become a political football between the Democratic and Republican parties, with each trying to drum up support for different projects. Lawmakers also are said to have squabbled along partisan lines as to how to pay for the new package without contributing to the growing national deficit. The bulk of the original $10.4 billion price tag was planned to be financed by selling oil from the US Strategic Petroleum Reserve, but other legislative initiatives raiding those coffers forcing the bill’s supporters to seek other sources of revenue. The total cost is now believed to have been whittled down to $8.75 billion or even less.

Monies for the “cancer moonshot” being pushed by US Vice President Joe Biden, who lost a son to brain cancer last year, are also to be included in the new legislative package – MD Anderson Cancer Center in Houston, Texas, is creating a chair endowed with $1 million in honor of Beau Biden. The bill also would seek $1 billion in grants to states to fight opioid abuse. A provision dear to the hearts of parts of the pharmaceutical industry, designed to keep generics to treat rare diseases off the market for a longer period, may have been scuttled.

Various interest groups are claimed to have spent as much as $500 million on lobbying for and against provisions of the legislation in 2015 and the first half of 2016.  Efforts by the Pharmaceutical Researchers and Manufacturers of America (PhRMA) to assert its influence amounted to $24.7 million of the organization’s $30.3 million lobbying budget, one report said.

While some nonprofit advocacy groups such as Public Citizen and R&D groups such as the National Center for Health Research opposed the bill, citing concerns that patients’ health could be endangered if the approval of new medicines and medical devices were simplified, universities, medical schools and patient groups funded by drug and device manufacturers have been holding their hands out, critics contend.

Congressional negotiations were said to be continuing early this week as Democratic legislators sought additional changes to garner strong bipartisan support for addressing mental health issues. Once the House acts on the bill, a vote in the Senate is scheduled to follow before the end of December.