The FDA documents show the five doctors were alerted as part of a wide-reaching federal probe involving Gallant Pharma International Inc., which sold more than $12.4 million in unapproved chemotherapy and injectable cosmetic drugs in the United States before the government shut down the operation in 2013.
The letters to the doctors, dated April 1, 2015, say that “In addition to putting patients at risk, receiving misbranded or adulterated drugs and devices in interstate commerce and delivering or offering to deliver those drugs and devices to (or use on) others violates federal law.”
None of the doctors has been charged with wrongdoing, and only one acknowledged receiving the letter from the FDA.
The case comes to light as drug companies and pharmacies are urging Congress and law enforcement officials to crack down on an increasing number of dangerous unapproved and counterfeit drugs being sold to doctors and consumers nationwide. Sales of counterfeit drugs and drugs not approved by FDA have soared into a multi-billion dollar industry with the growth of the Internet, and drug companies say efforts by governments to tackle illegal online drug sales are not sufficient.
U.S. Sen. Richard Blumenthal, D-Conn., said the FDA should be referring its Gallant Pharma investigation results to state medical commissions that have “licensing oversight over physicians.”
If the FDA believes a provider violated federal law, “The Department of Justice can take criminal enforcement action in the same manner as when health care providers overprescribe opioids or commit Medicaid fraud,” Blumenthal said. He said he planned to contact the FDA “to determine if there is any need for further Congressional action.”
Gallant distributed more than 17,000 units of unapproved drugs to medical practices in the United States between August 2009 and August 2013, and “it is not known, whether any of the drugs or devices are still in distribution,” the FDA said.
Individuals who ingest fake or counterfeit drugs may be at risk of a number of dangerous health consequences, including unexpected side effects, allergic reactions, or a worsening of their medical condition, according to the FDA.
In a recent briefing to House staffers, Thomas Kubic, who represents 33 drug manufacturers as CEO of the Pharmaceutical Security Institute, outlined the Department of Justice actions against Gallant and other illegal drug sellers.
“Although there have been some enforcement operations, we haven’t seen a decrease in unapproved and counterfeit drugs,” Kubic said, in an interview with C-HIT. “Criminals are making billions of dollars from counterfeits.”
Of the five doctors who were mailed FDA letters, only two would fully discuss Gallant.
Dr. David Kloth, the medical director of Connecticut Pain Care in Danbury, said three or four of his patients with chronic headaches and other “pain syndromes” were denied Botox injections by their insurance carriers in 2011 and wanted to pay on their own for the drug.
“We had heard of a mail-order pharmacy in Canada that would provide them the drug at half the cost ($350 instead of $550 per vial),” Kloth said. Only one of his patients agreed to buy the Botox, he said, and the patient had “no detrimental effects.”
“We stopped using this company because of the difficulties with the process and our concerns about the legality of buying from Canada,” Kloth said.
Kloth said the drug received from Gallant was the same product—in an identical bottle and packaging—as a more expensive one supplied by Allergan, which sells FDA-approved Botox. The Gallant product, he said, “was made by Allergan, shipped to Canada, and we bought the exact same material but from a Canada distribution pharmacy at a fraction of the cost.”
Dr. Jeffrey Gold, an ophthalmologist at Laser Body Solutions in Hamden who was sent an FDA letter, said he had never heard of Gallant Pharma, didn’t buy drugs from the company and didn’t recall receiving a letter from the FDA informing him that he may have bought drugs from the company. He said he uses Botox made by Allergan.
Dr. Jonathan Kost, the medical director of pain programming at Hartford Hospital, said he hadn’t heard of Gallant Pharma and was unaware of the FDA letter.
Dr. David Feingold of Physical Medicine & Rehab of Hartford, LLC did not respond to repeated requests for comment.
Dr. Matthew Raymond of CT Rehabilitation & Spasticity Care, LLC of Southington also did not respond to repeated requests for comment.
According to a grand jury indictment against one of Gallant’s employees, Patricia Durr of Massachusetts sold more than $699,000 of Gallant drugs and devices to doctors and hospitals in Connecticut and Massachusetts. Also, Durr sold “240 vials of misbranded Botox for $90,000 to a doctor in Southington, Connecticut.” The name of the doctor was not disclosed.
FDA spokesman Chris Kelly said that the agency does not have the authority to monitor doctor-patient affairs and does not know how many patients may have taken or been harmed by the drugs.
Criminal Case Against Gallant
In May 2014, Gallant Pharma co-owners Talib Khan and Syed Huda were sentenced to three years in prison after they and 10 others employed or associated with the company pled guilty to criminal charges.
The FDA in July 2015 permanently debarred Khan, Huda and three others who pled guilty, including Durr. The debarring prohibits them from “providing services in any capacity to a person having an approved or pending drug product application.”
Durr refused comment to C-HIT about drug sales she made in New England.
According to a 2013 grand jury indictment, Gallant Pharma executives working in Virginia had foreign accomplices ship drugs to the United Kingdom and Canada, and then other accomplices in those countries shipped them to Virginia. Many of Gallant’s drugs were subject to strict temperature controls to protect drug potency, but the company, according to the Department of Justice, received and shipped the drugs with ice packs that “sometimes melted—not with dry ice used by legitimate drug distributors.”
Also, many of Gallant’s drugs did not have a FDA-required “black box” warning indicating they could have life-threatening adverse effects, the Justice Department said.
Roger Bate, an economist and an expert on international health policy and counterfeit drugs, said it’s “extremely vital” that drugs for cancer, epilepsy and some other conditions are “perfectly manufactured” and properly shipped. If not, the drugs “may be fatal or useless,” said Bate, author of “Making A Killing: The Deadly Implications of the Counterfeit Drug Trade.”
Gabriel Levitt, the president of PharmacyChecker.com, says many drugs available in foreign countries are the same ones sold domestically but are much cheaper, or foreign versions of FDA-approved drugs that are safe, effective and less expensive.
Bate and Levitt agree that the FDA needs to identify the safest online pharmacies abroad, as well as crack down on rogue operations. Too often, they say, drug companies and U.S. pharmacies push law enforcement authorities to act and try to maximize profits by lumping together unscrupulous counterfeit drug sellers with sellers of safe, less expensive drugs.
“We are all for cracking down on people selling unsafe, dangerous medications,” Levitt said, “but we are really against conflating those issues with Americans who buy safe, effective medications abroad because they can’t afford them domestically.”
Kloth, the Danbury doctor, said Americans “are being ripped off” by drug prices, and complained that the federal government “does nothing to protect the American people from these exorbitant prices.”
He said he recently bought medication at a pharmacy that cost more than $300, though it cost $10 to produce and was sold for less than $40 several years ago. “Why should the same medication be half the cost in Canada?” he asked.
Blumenthal said consumers should be allowed to buy drugs that are more affordable from foreign pharmacies, but that “very rigorous safeguards” must be in place to protect against unsafe drugs.
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