‘PATIENTS’ FDA Act’ would tighten Congress’ grip on FDA (Best of MedCitizens)

April 21, 2012 8:40 am by Frank Vinluan | 0 Comments

Every week, MedCity News highlights the best of its MedCitizens: syndication partners and MedCity News readers who discuss life science current events on MedCityNews.com.

Now here’s the best of what YOU had to say:

The “PATIENTS’ FDA” Act — An Unexpected Legislative Initiative. “Many of those most familiar with the workings of the FDA would argue that this agency is chronically underfunded — given its responsibilities for overseeing the safety of a vast range of products from food and drugs to cosmetics, diagnostics, and medical devices. The proposals put forward by Senators Coburn and Burr would likely increase the financial pressures on the FDA unless they were associated with a considerable increase in its annual appropriation (above and beyond the proposed increase in users fees). Such an increase in the FDA’s appropriation for 2013 would not appear to be an agenda item that correlates well with Republican desires to lower the federal budget by many billions of dollars.”

Doctors may soon face as many unnecessary exams as patients. “Over the past 20 years huge demands have been piled onto practicing physicians, pulling them out of their practices, expecting them to take costly review courses and having them spend thousands of dollars to re-certify in their specialties. While this MOC might sound reasonable, less than 5% of doctors feel that this makes them better able to care for patients. Specialists find that the tests are outdated, not surprising since it takes time to develop questions, and prepare and administer exams. Who needs this?”

Genomics — a Revolution in Medicine — Part 2. “Genomics can be used for early diagnosis, especially in the field of infectious diseases. Remember the gentleman who flew to Italy on his honeymoon but who had tuberculosis? It led to an international concern that he might have infected others and that his TB might be of the drug resistant variety. One of the problems was that it takes about six weeks to grow the TB bacteria in the laboratory and then, if present, another six weeks to test for antibiotic susceptibility. But genomic tests can speed that process up to just hours.”

ACA’s 2013 medical device tax has already killed jobs, expansion plans. “It’s disingenuous to say that that level of taxation will not lead companies to locate new factories and research and development arms outside of the U.S. Foreign manufactures have a clear price advantage by paying a tax bill that can be half what a comparable U.S. firm will pay. Academic claims that the tax will not have an impact on U.S. jobs is na ve and does not match reality. Medical device companies have signaled a warning for several months now.”