Dr Richard Lee (Xandrox) faces federal charges
Four men, including two Utahns, face federal charges for allegedly selling hair replacement drugs over the Internet without U.S. Food and Drug Administration approval.
SALT LAKE CITY - Four men, including two Utahns, face federal charges for allegedly selling hair replacement drugs over the Internet without U.S. Food and Drug Administration approval.
Dr. Richard Lee, 72, and James Dorius, 69, both of Whittier, Calif., owned Regrowth, LLC, a business that made and sold hair treatment drugs online. Alexander Ahn, 32, and Min Kim, 32, both of Provo, ran a Utah company called Minoxidil Solutions that sold the drugs after Regrowth had agreed with the FDA to pull them from the market, according to the indictment.
The indictment alleges that the FDA discovered that Regrowth was selling drugs Lee made using his own formulas and recipes dating back to 1996. Some of the products contained active pharmaceutical ingredients.
The company was not registered with the FDA and did not seek or obtain approval to sell its hair growth drugs, according to the indictment. As a part of an agreement with the FDA in February 2011, Lee stopped selling the products and sent customers an "urgent drug recall" notice informing them of potential health hazards.
Two months later, Lee and Dorius delivered Regrowth's remaining drug ingredients and manufacturing equipment to Kim and Ahn in Utah. According to the indictment, Kim agreed to pay Lee and Dorius half of what Minoxidil Solutions earned on the sale of hair growth drugs made using Lee's ingredients and formulas.
"These kinds of cases are important because in many instances individuals are advised by FDA that they cannot lawfully manufacture and sell unapproved and misbranded drugs, yet even after warning, they continue to manufacture and sell these prohibited drugs," said Patrick J. Holland, special agent in charge of the FDA criminal investigations office in Kansas City.
Lee, Dorius, Ahn and Kim are charged with conspiracy to introduce misbranded drugs into interstate commerce, which carries a penalty of five years in prison and a $250,000 fine.
All four men are scheduled for an initial appearance in U.S. District Court on Oct. 23.
This throws light on the relations between Regrowth amd Minoxidil Solutions and would seem to confirm my view that the early Minoxidil Solutions Xandrox 15s were more or less the same as Lee's; and only later did they run into quality control issues. It also throws light on the precise wording of the 'urgent recall' notice, confirming that this was part of an 'agreement' between Richard Lee and the FDA.
I would like more information on 'unapproved and misbranded drugs.' The scope of the 'misbranded drugs' definition of the charge is very wide, indeed,
I would also like more information on Dr Lee's qualifications, the ethics of passing on his 'patient' lists to third parties, and his likelihood/liability, or otherwise, to be 'struck off' any medical register he may be on (as we would say in the UK), if found guilty of any relevant breach.