
Google Was Warned on Rogue Drug Ads  - lotusleaf1987
http://online.wsj.com/article/SB10001424052748704083904576335483063623402.html?mod=djemalertTECH
======
ramanujan
This article is a canonical example of regulatory capture. Large pharma
companies and licensed pharmacists alike do not like the idea of overseas
pharmacies selling into the US market. Each large pharma company was forced to
pay about a billion dollars per drug for a license from the FDA, so they have
an incentive to recoup costs. And the FDA also has an incentive to play
policeman and thump its chest about "safety" to justify a budget increase.

In reality, removing the FDA from the equation would be much better than
eliminating online pharmacies. Open it up and let the buyer beware, just like
they already do about every other internet site they visit.

~~~
tptacek
_The problems included failing to require a doctor's prescription, improperly
selling controlled substances or peddling fake or tainted drugs. Many illicit
pharmacies appear to be based in Canada but often ship drugs from places like
India, Barbados or China, according to the FDA._

Regulatory capture. Right. That's what this is about. The ideological debate
over whether any drugs should be regulated. Sure.

~~~
ramanujan
I was going to write a long post on this, but I sense that you're coming from
a background of different premises. May I simply suggest that the FDA often
cries wolf, and vastly exaggerates threat levels associated with things
outside their supervision? I will cite two examples and leave it at that for
now.

1) Here is the FDA's 2009 testimony on drugs imported from Canada. Note how
they endorse a denunciation of imports in the harshest terms, stating that
Canadian imports of "unapproved drugs" are a "violation" that "put Americans
at serious risk".

    
    
      http://www.fda.gov/NewsEvents/Testimony/ucm114735.htm
    
      On November 6, 2003, Federal District Court Judge Claire 
      V. Eagan, U.S. District Court for the Northern District of 
      Oklahoma, issued a decision in United States v. RX Depot, 
      Inc. and RX of Canada LLC, granting a preliminary 
      injunction to immediately prevent these defendants who 
      operate business that import prescription drugs from 
      Canada, because such unapproved drugs were a clear 
      violation of the FD&C Act. In addition to her unequivocal 
      findings of law, the Judge concluded that these companies 
      could not assure the safety of the drugs they have been 
      importing and, as a result, in violating the law have put 
      Americans at serious risk.
    

These are Canadian pharmacies we're talking about. It's not exactly Somalia up
there.

2) Here is a sample FDA warning letter to UltraRad from May 2009. All of these
letters always start out like a horror story:

    
    
      http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm173977.htm
    
      This inspection revealed that this device is adulterated 
      within the meaning of section 501(h) of the Act, 21 U.S.C. 
      § 351(h), in that the methods used in, or the facilities 
      or controls used for, its manufacture, packing, storage, 
      or installation are not in conformity with the Current 
      Good Manufacturing Practice (CGMP) requirements of the 
      Quality System (QS) regulation found at Title 21, Code of 
      Federal Regulations (C.F.R.), Part 820. No written 
      response was received from you concerning our 
      investigator's observations noted on the Form FDA 483, 
      List of Inspectional Observations that was issued to 
      William J. Giunta, Vice President of Service, on March 5, 
      2009. These violations include, but are not limited to, 
      the following...
    

Wow, "adulterated", that sounds awful! What were these terrible violations?
Let's read further down:

    
    
      4. Failure to validate computer software for its intended 
      use according to an established protocol when computers or 
      automated data processing systems are used as part of 
      production or the quality system as required by 21 CFR § 
      820.70(i). This was a repeat violation from a previous 
      FDA-483 that was issued to your firm. For example:
    
      A) Your firm uses off-the-shelf software (HEAT Help Desk) 
      to manage customer support service calls and to maintain 
      customer site configuration information; however, your 
      firm failed to adequately validate this software in order 
      to ensure that it will perform as intended in its chosen 
      application. Specifically. your firm's validation did not 
      ensure that the details screen was functioning properly as 
      intended. The details screen is used to capture complaint 
      details and complaint follow-up information which would 
      include corrective and preventative actions performed by 
      your firm when service calls are determined to be CAPA 
      issues.
    
      B) Off-the-shelf software (Microsoft SharePoint) is being 
      used by your firm to manage your quality system documents 
      for document control and approval. However, your firm has 
      failed to adequately validate this software to ensure that 
      it meets your needs and intended uses. Specifically. at 
      the time of this inspection there were two different 
      versions of your CAPA & Customer Complaint procedure, SOP-
      200-104; however, no revision history was provided on the 
      SharePoint document history. Your firm has failed to 
      validate the SharePoint software to meet your needs for 
      maintaining document control and versioning.
    

I cite this particular example solely because you as a software engineer have
the expertise to see how ludicrous this citation is. They are literally saying
that a small business needs to do "software validation" of a multibillion
dollar product like Microsoft Sharepoint to "ensure that it meets [their]
needs and intended uses".

This was the grounds for claiming that UltraRad's product was "adulterated",
trashing their reputation on the internet and exposing them to fines and
penalties.

So: all I ask is that you read through a sample of FDA warning letters
sometime with a more skeptical eye, keeping in mind that their form of writing
is highly optimized for surface optics. Focus on the claimed software
violations and try to translate them into plain English and you will see there
is often not much there. This may shift the needle on your premises about
whether the FDA is credible when it cries "catastrophe unless we regulate".

