I see doctors who work for drug companies the same way I see scientists who work for big energy companies, not entirely trustworthy or without bias. They're in the tank because of where their bread is buttered. And I don't think it would be safe or responsible to let doctors prescribe unproven drugs at their say so, unless it's a clinical trial or supervised experimental situation. There has to be oversight.
I'm not referring to letting doctors who work for drug companies decide to prescribe something. I'm referring to individual doctors in clinical practice deciding what drugs to prescribe for people under their care whether it's FDA approved for that condition or not. It happens already once a drug is on the market. It's called prescribing "off label". www.webmd.com/a-to-z-guides/features/off-label-drug-use-what-you-need-to-know#1
The next time your doctor writes you a prescript
ion, consider this: The medication may not be approved for your specific condition or age group.
But you probably shouldn't call the medical board. The practice, called "off-label" prescribing, is entirely legal and very common. More than one in five outpatient prescript
ions written in the U.S. are for off-label therapies."Off-label" means the medication is being used in a manner not specified in the FDA's approved packaging label, or insert.
ion drug marketed in the U.S. carries an individual, FDA-approved label. This label is a written report that provides detailed instructions regarding the approved uses and doses, which are based on the results of clinical studies that the drug maker submitted to the FDA.
“Many people may be surprised to know that the FDA regulates drug approval, not drug prescribing, and ... doctors are free to prescribe a drug for any [reason they think is medically appropriate],” says G. Caleb Alexander, MD, MS, a medical ethics advocate and assistant professor of medicine at the University of Chicago Medical Center. "Off-label use is so common, that virtually every drug is used off-label in some circumstances."
Would you consider this a dangerous lack of oversight?
Fast tracking drugs through the FDA, letting doctors decide does nothing to costs anyway, so I'm finding your point irrelevant. Drug companies have a vested interest in getting drugs through the FDA and it ain't to provide them cheaper to patients. Drugs are approved at a much faster rate these days but if it's not a drug that will be used widespread, say like Humira, then a drug company has no interest.
What makes you think that drugs are approved at a "much faster rate these days"? According to the FDA the NDA (new drug approval) process takes between 7.6 and 19 years:www.fdareview.org/03_drug_development.php
Did it used to take much longer? I think that the pharmas would like to see all of their applications go through a few years faster, regardless of the potential market size. If the drug wasn't commercially viable they wouldn't have developed it.
And the issue with generics is are they as effective? Are the ingredients the same? Is the manufacturing process up to standards? Would I want to find out the hard way they aren't? Not really.
Generics should absolutely have to go through an approval process. I never suggested otherwise. Reread my original post a little more carefully. My issue is with the huge backlog and lengthy process the FDA has in place. This is from the NPR article I linked to earlier:
As of July 1, the FDA had 4,036 generic drug applications awaiting approval, and the median time it takes for the FDA to approve a generic is now 47 months
, according to the Generic Pharmaceutical Association, a trade group. The FDA has approved more generics in the past few years, but a flood of applications has added to the problem.By comparison, the European Medicines Agency, Europe's version of the FDA, has just 24 generics, including biologically based biosimilars awaiting approval
. The FDA's generic count doesn't include biosimilars, which are more complicated medicines to review. The EMA along with the European Commission, which handles approval of marketing materials, are approving generics and brand-name drugs in about
a year on average, according to the EMA.
Critics say getting generic alternatives to the U.S. market for products like EpiPen is still taking far too long. Other off-patent drugs with rising prices and no generic competition have also drawn scrutiny, including Turing Pharmaceuticals' Daraprim, for toxoplasmosis, and Valeant's cardiovascular drugs Isuprel and Nitropress.
So somehow the European equivalent of the FDA manages to do this with essentially no backlog (24 applications waiting vs over 4,000) , and in the US it's a 4 year wait. That means that Europeans are paying generic prices for thousands of medications that have lost patent protection while we're stuck paying monopoly pricing for the brand name version.
As I said, this does not serve the American people well.