Google Was Warned on Rogue Drug Ads

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".

I don't think anyone wants pharmaceutical drugs not be be tested. The issue is whether consumers should be free to choose who does their drug testing or whether government should take away that choice and force everyone to test drugs with the FDA. The FDA is a government monopoly and not answerable in court if it screws up. I think the public would be better off if testing were done by entities without these characteristics.