Much has been made lately, at least in headlines, about the amount of money spent by medical device companies in lobbying the U.S. government. ("Medtronic spent over $1M lobbying gov’t in 2Q", "Boston Scientific spent $480K lobbying gov’t in 2Q"). No caveat is placed on these headlines, as if they self-sufficiently scream "too much!"
Put succinctly, here is the problem I have with these headlines. They are intended to induce a reaction, as if these companies have attempted to bribe the government, or worse.
For companies with billions of dollars in annual revenue, it would be foolish and irresponsible to not spend this kind of money to ensure that their interests are represented in Congress, which, by virtue of being beholden to voters, shifting political winds and other capricious forces, can sometimes pass contradictory, damaging and illogical legislation.
Case in point (legislation, that is, not necessarily illogical), the Medical Device Safety Act, legislation to remove the shield protecting manufacturers from liability lawsuits from product failures. To be on record, I endorse MDSA for its principles of disassociating the FDA’s approval of safety and efficacy from the demands that products be made free from foreseeable defects and other potential causes of injury and death. But, if the industry does not make its case for the legislation that is enacted, how it is enforced or other aspects of the law, then the legislation may place needless burden on the device industry, which in turn may limit resources for continued medical product development.
Of course, it is not en vogue to be in support of the medical device industry. Much more attention has been given to product failures and, in the midst of one of the worst recessions the country has every faced, the industry’s steady and continued profitability (despite the fact that there have been a plethora of medical device company bankruptcies, see below, since this recession began) . The truth is that it is in the interest of the industry to defend their economic interests which, if effectively accomplished, also protect the interests of patients in the long run. The industry is not well served by being shielded from its obligation to responsibly manufacture products. Conversely, patients demand, almost irrationally, solutions to their healthcare problems as if their bodies are under warranty by physicians and manufacturers. Medical device and other healthcare product manufacturers are only too happy to innovate and attempt to serve this demand, but if the legislation to reign in manufacturers becomes the least bit restrictive, then innovation, which has already been hit by the recession’s adverse financing, will be markedly diminished.
Recent healthcare company bankruptcies (or possible soon): Innovative Spinal Technologies, Xtent, Adaltis, Axcess Medical Imaging, Scantek Medical, Maxxim Medical, Artes Medical, Haemacure, Argolyn Bioscience, Aspen Medtech, Allux Medical, Luna Innovations.