Former FDA official hits out at drug companies that engage in profiteering
A former deputy commissioner of the FDA has stated that the drug industry should be subject to the same profiteering laws and sanctions as other industries. They also need to follow strict identity checks that are to be maintained by business software provided by businesses like www.w2globaldata.com/regulatory-compliance-solutions-and-software/aml-id-checks/ who specialise in AML Identity check. The comment came following widespread outrage over the extortionate price hikes in Mylan’s lifesaving EpiPen, which currently retails at more than £450.
Unjustifiable price hikes
Dr Joshua Sharfstein told sources that drug companies are essentially playing by their own rules when it comes to increasing prices when there is high demand. Dr Sharfstein used the example of gasoline companies being held to account by the law if they were to increase prices during a hurricane, which is an illegal move, and asserts that companies such as Mylan have been able to increase the cost of products such as the EpiPen by approximately 400 per cent in just a few short years. He maintains that these costs are unnecessary, extortionate and should be carefully policed.
“We’re not talking about new drugs with a high cost of research and development here,” Dr Sharfstein added. The essential problem, he asserted, is that offending companies are increasing their charges when there has been little to no innovation.
During a recent interview, the current CEO of Mylan, Heather Bresch, struggled when pressed to justify the enormous price increase of the EpiPen.
Competitors and Innovation
For many emerging drug companies that must compete to keep their overall research and trial costs down, the most pressing question is often ‘How long does it take to get an FDA 510k approved?’ This can vary enormously from company to company and makes it increasingly difficult to compete with major companies, which can take a medical product from design to production to retail stage very rapidly.
Many newer companies are now choosing experts to manage their time – and budget – effectively to compete with the major names. The pricing of large drug companies continues to make the news worldwide, with Britain’s BBC news recently reporting that a price has not yet been settled on for an innovative gene therapy drug due to be made available by one of the world’s largest drug companies.
Dr Sharfstein finally commented that the FDA could relieve the problem in a number of ways, in particular by prioritising ‘second competitor’ over ‘19th competitor’ drugs.