Gilead reveals again: $250 million in counterfeit AIDS drugs flowed into the U.S. market

In two years, 85,247 bottles of counterfeit versions of the two drugs were sold, worth about $250 million;

In the first half of 2021, the Food and Drug Administration investigated and dealt with 3,958 cases of production, sale and use of counterfeit and inferior drugs, worth 38.

The counterfeit drugs on the market, whether abroad or at home, whether by regulatory agencies or pharmaceutical companies, are being severely cracked down

01 Fake HIV drugs

Recently, Gilead issued an announcement saying that its HIV drugs Biktarvy and Descovy were counterfeit

HIV virus can cause human infection with AIDS, paralyze the human immune system, and then lead to human infection of other diseases or tumors, affecting life and health and even threatening life safety

Biktarvy was approved in the United States in 2018 for the treatment of HIV-1 infection

Descovy was approved for marketing in the United States in 2016 and is used in combination with other HIV-1 drugs to treat HIV infection in patients weighing ≥14kg

According to Gilead’s 2021 third quarter financial report, as of September 30, 2021, global sales of Biktarvy and Descovy have reached $2.

Regarding the production and sales process of counterfeit drugs, Gilead said that the people who make the counterfeit drugs put the counterfeit drugs in the bottles of Gilead's original drugs, then reseal them, and then sell them to pharmacies through distributors that are not authorized by Gilead.

According to Gilead, counterfeit drugs that come in original bottles are often over-the-counter pain relievers or antipsychotics

Gilead, along with the FDA, seized drug vials with Gilead labels from 17 locations in nine U.

In August last year, after filing a lawsuit, Gilead posted an announcement on its website telling consumers that counterfeit HIV treatment drugs were circulating in U.

Today, Gilead once again stated that it will continue to work closely with the FDA and law enforcement to eliminate counterfeit drugs in circulation in the U.

In the lawsuit, the presiding judge has ordered the defendant distributors to stop selling Gilead-branded drugs, said Lori Mayall, Gilead's top anti-counterfeiting executive

02 The counterfeit chemical and traditional Chinese medicine

The counterfeit drug incidents that Gilead has encountered in the US market have also been encountered by some multinational pharmaceutical companies and domestic local pharmaceutical companies in the Chinese market

In July last year, the China Anti-Infringement and Counterfeiting Work Network published two extremely large cases of counterfeit medicines, involving the production and sale of counterfeit medicines, including Pfizer's "Lipitor", Sanofi's "Plavix" and Chinese herbal decoction pieces

Defendant Wang Xialing (pseudonym) and other 15 people sold "Lipitor" and "Plavix" to the whole country through WeChat and QQ groups

When they were arrested, the police of the Public Security Bureau detained 198 kilograms of "Lipitor" pills, 20 kilograms of "Polavit", production materials and production equipment in the workshop and garage rented by Wang Xialing
.
In the end, Wang Xialing was sentenced to 12 years in prison and fined 1.
88 million yuan
.
The other 14 defendants were sentenced to imprisonment ranging from six months to eight years and four months, with fines ranging from fines
.

In addition to chemical drugs, there is also the production and sale of counterfeit drugs in the traditional Chinese medicine market
.

Since February 2018, 14 people including Li Moumou and Ding Mou began to produce, process and sell male health traditional Chinese medicine drinks
.
By falsely using other companies' food production qualifications and batch numbers for packaging, and then falsely advertising the functions and efficacy of drugs through the Internet to sell counterfeit drugs to consumers
.
The amount of sales involved is as high as more than 7.
6 million yuan
.
In the end, Li Moumou and other 14 people were sentenced to fixed-term imprisonment ranging from 12 years to two years and fined
.

For cases of counterfeit medicines, our laws have never tolerated them
.

According to Article 98 of Chapter 10 of the "Drug Administration Law", any of the following circumstances is a counterfeit drug: (1) The ingredients contained in the drug do not conform to the ingredients specified in the national drug standards; (2) The non-drug is passed off as a drug Medicines or other medicines pretending to be such medicines; (3) Deteriorated medicines; (4) The indications or functions indicated on the medicines are beyond the prescribed scope
.

Article 118 stipulates that if the production or sale of counterfeit medicines, or the production or sale of inferior medicines and the circumstances are serious, the legal representative, main responsible person, directly responsible person in charge and other responsible persons shall be confiscated during the illegal act.
The income obtained from the unit shall be subject to a fine of not less than 30% but not more than three times the income received, a lifetime ban on drug production and business activities, and a detention of not less than 5 days but not more than 15 days by the public security organ
.

China's law enforcement is very strict with regard to illegal production and sales of counterfeit drugs
.
But even so, driven by interests, some people still take risks
.

The Food and Drug Administration has also investigated and dealt with a number of drug violation cases
.
According to the "Statistical Report on Drug Supervision and Administration" (the second quarter of 2021), from January 1, 2021 to June 30, 2021, a total of 20,167 drug violation cases were investigated and dealt with nationwide during the reporting period, with a total value of 19,412.
01 million
.
A total of 400.
6927 million yuan was fined, 81.
6091 million yuan of illegal gains were confiscated, 24 counterfeit dens were destroyed, 145 were ordered to suspend production and business (including 13 production enterprises and 132 operating enterprises), and 13 licenses (including production licenses) were revoked.
1 license and 12 business licenses), and 157 were transferred to judicial organs
.

Among them, in the production and sale of counterfeit and inferior drugs, a total of 3,958 cases of production, sale and use of counterfeit and inferior drugs were investigated (including 19 cases of selling counterfeit and inferior drugs through the Internet), with a value of 38.
8721 million yuan and a fine of 130.
9552 million yuan, which were transferred to judicial organs.
100 pieces
.

(Source: Statistical Report on Drug Administration (Second Quarter 2021))

The heads of the Supreme People's Procuratorate, the State Administration for Market Regulation and the State Drug Administration have stated that the production and sale of counterfeit medicines directly endanger the lives and health of the people and cause great harm to society
.
The drugs involved in the case were counterfeit drugs from regular manufacturers, and they were all counterfeit drugs that did not meet the national drug standards
.

Medicine is a special commodity closely related to the life, health and safety of the general public, and is also an important "weapon" for human beings to fight against diseases
.
If there are counterfeit and inferior medicines on the market, it may cause the patient's condition to be delayed, affect their health, or even aggravate their condition, even endangering their lives
.
The crackdown on the production and sale of counterfeit and inferior drugs is not only the responsibility of the regulatory authorities, but also a key way for pharmaceutical companies to protect their own brands and rights, and it is also an important guarantee for the life, health and safety of consumers
.