IHRB is pushing its luck in trying to appeal the decision by the Therapeutic Goods Administration that has slapped IHRB with a Regulation 9 Order. The Order prohibits IHRB from publishing its ‘unlawful, misleading, and unverified’ advertisements. It also requires IHRB to publish retractions, and to erase most of its website. IHRB’s letter to the Minister for Health was received 22 April 2014, in which Mr Sam Cohen requested a Review under Regulation 48 of the Therapeutic Goods Regulations 1990 (in relation to the ‘initial decision’ by the Delegate).
Mr Cohen does not seem to want to grasp the fact that he must, by law, comply with the Order. As at 12 May 2014, he is 75 days in breach of the Regulation 9 Order, and 2 years and 184 days in breach of CRP Sanctions [1].
Knowing Mr Cohen as I do, I suspect he is advising his clients that the Order is unfair and irrelevant, and is currently being challenged and disputed. I have no doubt he is bamboozling people about its validity, and probably saying something like, ‘I am appealing the stupid decision…’
IHRB MUST COMPLY WITH THE ORDER
Indeed, the TGA will follow the due process to review the Decision. However, this does not mean that IHRB can ignore the Order. As you can see at this link [2], the TGA says, ‘Following receipt of a Regulation 9 order, an advertiser may seek reconsideration of the decision by the Minister under regulation 48 by lodging a written request within 90 days after the decision first comes to its notice.
‘The lodging of a request for a review of a decision does not affect the operation of the decision made under regulation 9. It remains in effect and must be complied with unless and until it is varied or set aside on review or another order affects it.’
$33,000 PENALTY
The law says that anyone who fails to comply with the TGA’s Regulation 9 Order can be fined $33,000 for a corporation, and $6,600 for an individual. Then there would be legal costs. Perhaps a good prosecutor can fine both IHRB and Sam Cohen simultaneously.
Here we are, with the Complaints Resolution Panel [3] AND the TGA [4] both finding IHRB’s advertising and statements to be ‘unlawful, misleading, and unverified’, and Mr Sam Cohen of IHRB refusing to stop his hideous and flagrant disregard for the law.
Then again, knowing Mr Cohen as I do, after 4.5 years of investigating his misconduct and illegal actions, I am not surprised that he refuses to operate in an ethical manner as a citizen of this country. He just does not want to do the right thing, simply because if he were to ever do the right thing, his ONLY solitary option would be to shut down, and refund everyone’s money.
Doing the right thing means stopping his illegal operation, and complying with the Health Care Complaints Commission’s Permanent Prohibition Orders [5] and with the TGA’s Orders, which effectively means that he cannot sell any therapeutic products. Any product that can regrow hair is, ipso facto, a therapeutic product. IHRB is prohibited from supplying or selling therapeutic products… and so you see the infinite loop.
Sam Cohen must shut down and stop operating! There is no other way. Alas, Mr Cohen will fight on, because he does not care. He never cared. His is now a game of proving that Australia is a weak country with useless Departments. That’s what he told one of his clients, who relayed this mockery to me. Mr Cohen finds it amusing that in Australia, one can get away with so much. How right he is. But then again, as I said four years ago, ‘I see a brick wall coming…’
UPDATE: According to the TGA, the appeal has been withdrawn, and the original Order now stands. However, despite publishing a retraction on its website, IHRB is still in breach of the Order!