Memo to SCOTUS: Cut the FDA Down to Size

In my column this week for Hoover’s Defining Ideas, I argue that the FDA is not only standing between sick patients and crucial drugs, it is violating the prohibition against free speech. The problem is its policy about the off-label promotion of drugs. 

Between 25 and 60 percent of drugs are prescribed for off-label uses. For cancer patients, that number may be as high as 65 percent. The bottom line is that these drugs help sick patients recover and they save lives. Yet, the FDA criminally prosecutes drug companies that promote and publicize any off-label uses of drugs. If the off-label uses are indeed beneficial, anything that slows down their dissemination could mean the difference between disease or recovery—life or death—in thousands of sick individuals. The unbounded power of the FDA to block the use of such drugs does not square with any defensible conception of individual autonomy or freedom of speech. The FDA is vulnerable. The Supreme Court should cut it down to size.

I elaborate on these issues and more over at Defining Ideas.

  1. Scarlet Pimpernel

    In general, the same principle that suggests that the Court defer to the legislature–in a democratic republic the unelected branch defers to the Constitutional interpretation of the elected branch–cuts the opposite way with regard to the least democratic branch.  In general, the Court should apply strict scuitney to unelected officials who have, in effect, the right to make, law, enforce law, and judge the law.  If there is a question, they should have to go back to Congress to get additional power. Similarly, if they seem to be undermining the first amendment, the presumption should be against them.

  2. Devereaux

    For some reason your link won’t work for me, so I can’t read your commentary.

    That said, I would submit that the same approach should be taken to the EPA, the DOE, the DOJ, HEW (or whatever its current name is). We have way too much claptrap in federal government; most is detrimental to liberty; some simply useless (DOE).

  3. iWc

    I love the idea of free speech being applied to corporations. It is, ultimately, up to the consumer to determine what is right and wrong.

    And, of course, in a properly free market, certification organizations (like UL) can give their own seals of approvals on claims. Heck, the FDA could issue its own seal to those who meet their requirements, and people who need the government’s blessing to take a drug, can still do so.

  4. DocJay

    Pharmaceutical companies are highly predatory in their behavior. They buy up generic plants to keep prices artificially high and force states to not do business with Canada through various forced laws. They disseminate lies about bad results and sometimes it has consequences. Two heart attacks I’ve seen we’re from Vioxx I prescribed long after Merck was aware of the issue. The FDA are bribed and yet also incompetent. They fail to do the most critical aspects of their jobs, find out if things are safe, and yet drag their feet on critical life saving drugs. I had a man languish for five years waiting for telapivir for his Hep C. Finally he is cured but it could have been long ago. The FDA stinks. Big Pharma is crooked.

  5. liberal jim

    Current law requires drug companies to conduct phase 3 studies to prove that their drugs are effective in treating given conditions.  To allow them to promote the drugs for conditions that studies have not been conducted for makes no sense.  I think the FDA should only be concerned with the safety of drugs, but that is not the law.  

    To allow drug companies to promote the use of drugs for condition’s that they have not been approved for makes a mockery of the law as it has been written.   If the FDA has the power to determine if a drug can be marketed it stands to reason it has the power to say for what it should be marketed.    

    The FDA does not stop doctors from prescribing drugs it just stops drug companies from marketing them.  

  6. Eeyore

    Richard – just cut out the initial “http://ricochet.com/%2″ from your link  and it will work.

  7. Mendel
    liberal jim:  I think the FDA should only be concerned with the safety of drugs, but that is not the law.  

    To allow drug companies to promote the use of drugs for condition’s that they have not been approved for makes a mockery of the law as it has been written.   If the FDA has the power to determine if a drug can be marketed it stands to reason it has the power to say for what it should be marketed.   

    Agree completely – if we are touting the right of companies to exploit what is essentially a loophole in the law, something is gravely amiss.

    The best path would obviously be to reform the FDA’s mandate.  But as long as major change is not in the cards, perhaps a compromise would be to require pharma companies to add a disclaimer about “not (yet) approved for this condition) to their off-label promotions – giving consumers more information while not encumbering the advertising rights of companies.