Skip to comments.Device Review Slowdown Across FDA Impacting Medical Device Jobs
Posted on 02/22/2011 5:40:03 AM PST by Skeez
The California Healthcare Institute (CHI) and The Boston Consulting Group (BCG) have released a report highlighting the critical role of the U.S. Food and Drug Administration (FDA) in todays biomedical research and innovation ecosystem, and the need for a strong, science-based agency and an efficient, consistent and transparent regulatory process.
The report, , titled Competitiveness and Regulation: The FDA and the Future of Americas Biomedical Industry, has underlined that an increasingly unpredictable approval process at the FDA has negatively impacted public health, the economy, job creation, American competitiveness and innovation.
This report represents the first study to quantify approval timelines and trends over the past decade across both pharmaceuticals and medical devices using FDA and other data.
According to the studys findings, when comparing the most recent year with the average for 2003-2007, review times for drugs and biologics have increased by 28%; while for medical devices, 510(k) clearances have slowed by 43% and PMA approval times have lengthened by 75%.
Patients here in the United States ultimately suffer when there are delays in bringing new medical discoveries to the market, said David Gollaher, Ph.D., president and CEO of CHI, an entity that represents more than 275 leading biotechnology, medical device, diagnostics, and pharmaceutical companies, and public and private academic biomedical research organisations.
With foreign regulatory agencies, such as the European Medicines Agency (EMA), focused on enhancing the competitiveness of their industry as well as the safety of new drugs and devices, inefficiency at the FDA has resulted in American inventions being made available to patients and physicians in other countries first.
The report found that in recent years there has been wholesale movement of clinical trials abroad as well as new product launches targeting Europe years before the U.S. As far as the impact on pharmaceutical and medical device jobs is concerned, this shift has pushed jobs and revenues offshore, helping other nations gain experience in building infrastructure and scaling up new biopharmaceutical and medical technology products.
The report also cites the financial crisis of recent years as a contributor to the worsening biomedical innovation environment. Combined with regulatory uncertainty at the FDA, companies ability to secure necessary investment capital has been sharply reduced.
The FDAs expanded data requirements, changing clinical trials protocol, and lack of consistency all lead to high levels of regulatory uncertainty.
While this may have been uncomfortable in good economic times, it has become intolerable after the crash, said Simon Goodall, a partner in BCGs Health Care Practice. The business risk posed by regulatory uncertainty has increased sharply since 2007. With less capital available, the risk of FDA unpredictability and delays is only compounded, especially when European approval often offers a faster and more predictable pathway to commercialisation.
These bureaucratic log jams are a MAJOR reason why the cost of health care has been going up.
Why am I able to buy the same meds in Europe or Canada for less? The difference in price is almost totally due to trial lawyers and bureaucrats, two mainstays of dim party funding.
The finest health care system in the world is in MORE peril than most realize. Much has been written and spoken about the entire industry practicing “defensive” medicine, but this week I realized just how bad it has truly become.
For the last three nights, I have been tracking ATTORNEY commercials on cable TV. An appalling number of commercials urge people to seek legal advice, suggesting they are due “financial compensation” for this or that problem, however minor, after taking some specific medication.
These commercials insinuate the “BIG EVIL DRUG COMPANIES” create dangerous drugs merely for the sake of their profits.
Every last drug I’ve ever heard of has had an adverse effect on SOMEONE. Under today’s climate, even he who discovered Penicillin would be sued to bankruptcy or jailed. I think the last DRUG manufacturer to survive in the USA will be the one that closes down ALL research efforts and concentrates on making GENERIC copies of drugs whose originators have already been litigated to oblivion.
If and when the pubbies take control of all three branches of government, a top priority has to be shutting down the trial lawyer scams. In addition to caps, we need to insure that the jurors can understand stats and medical arguments, i.e., have an IQ above room temp.
Then we need a 90% windfall profits tax on attorney’s fees above $250K per case.