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Johnson & Johnson’s Licence for Cosmetics Cancelled

By: Pharma News | Views: 7108 | Date: 30-Apr-2013

15 batches of baby powder produced in 2007 were found to be sterilised by ethylene oxide, a known carcinogenicThe Food and Drug Administration (FDA) recently cancelled Johnson & Johnson India’s licence to produce cosmetic products at their Mulund plant. FDA’s order will come into effect from June 24.


Johnson & Johnson’s licence for cosmetics cancelled

Johnson & Johnson’s



15 batches of baby powder produced in 2007 were found to be sterilised by ethylene oxide, a known carcinogenic

The Food and Drug Administration (FDA) recently cancelled Johnson & Johnson India’s licence to produce cosmetic products at their Mulund plant. FDA’s order will come into effect from June 24.

Johnson & Johnson’s Baby Powder
 
According to FDA officials, the order was issued in a case dating back to 2007 when they found that 15 batches of Johnson & Johnson baby powder were sterilised by ethylene oxide, a known carcinogenic and irritant.
 
“While ethylene oxide can be used for sterilisation, the company did not bother to carry out a test after the process to check the amount of residue in the product,” said FDA joint commissioner KB Shende, adding that the company can appeal to the state government before the order comes into effect.
 
 “The products are used for new born babies. It is must for the company to follow all measures,” said Shende adding that the traces of ethylene oxide, if any, should have been measured. The 15 batches in question consisted of 160,000 containers.
 
When Mumbai Mirror contacted Johnson & Johnson, the company spokesperson confirmed the FDA action. “Nothing is more important to us than the safety of our products and health of the consumers. We continue to manufacture non-cosmetic products at the same site,” the spokesperson said, adding that the matter in question related to a limited number of batches produced in 2007, shelf life of which ended in July 2010.
 
“The FDA raised concern about following ethylene oxide treatment, which was not included as part of the manufacturing process submitted to the FDA. This method is widely used for medical devices around the world. This was followed as an exception and all internal safety protocols were followed to ensure that safety of the consumer was not compromised. In addition, we have ascertained that there were no complaints or unexpected/undesirable effect reported concerning any of the batches in question,” he said adding that the company is now in the process of filing an appeal with the state government.
 
What is Ethylene oxide? 
Ethylene oxide is a known carcinogen. The organic compound is known to be flammable, irritating, anaesthetic and carcinogenic at room temperature.
 
The USFDA has recommended that companies should measure the residue of ethylene oxide after sterilisation of products and before releasing the products in the market.  



Johnson & Johnson Denies Patent Pool Licences For HIV Medicines For The Poor


In a move public health advocates say is likely to bring negative consequences for low-income patients with HIV and AIDS, as well as negative publicity for the company, Johnson & Johnson recently announced that it would not enter into negotiations with the Medicines Patent Pool for voluntary licences that would allow several of key treatments to be made in more affordable generic form in developing countries.

The Patent Pool, founded and financed by World Health Organization affiliate UNITAID, “seeks to increase access to HIV medicines by negotiating with pharmaceutical companies for voluntary licences on their HIV medicines patents,” it said in a 20 December statement. The work of the Pool has received support from the WHO, UNAIDS, the Global Fund to Fight HIV, TB, and Malaria, and the Group of Eight industrialised countries, it said.

The Pool has reached licensing agreements with Gilead Sciences and the US National Institutes of Health, and is in negotiations with Boehringer-Ingelheim, Bristol-Myers Squibb, F. Hoffman LaRoche, Sequoia Pharmaceuticals, and Viiv Healthcare, a joint venture of GlaxoSmithKline and Pfizer. Generic companies have begun to take licences from the Pool, allowing them to make lower cost versions of new HIV treatments for use in developing countries, it said.

Johnson & Johnson issued an explanation of its decision, saying that its division Janssen had responded to an invitation from the Medicines Patent Pool early in the year by saying its current agreements with generic manufacturers were satisfactory, according to a copy of the explanation circulated by Knowledge Ecology International. But the company then agreed to hold a meeting with the Pool last spring, and afterward decided to revisit the decision until coming to the conclusion that it was not beneficial.

“So it is after a period of thorough deliberation and discussion, we have decided not to enter into negotiations with the MPP today,” it said, stressing its continued “responsibility and commitment” to needy patients in resource-limited countries.

At issue are three key HIV drugs: darunavir (marketed as Prezista) and etravirine (marketed as Intelence) – which J&J said are approved for use in treatment-experienced patients (3rd-line) in resource-limited countries – and rilpivirine (marketed as Edurant), which is for “treatment-naïve” patients. This received approval in the United States and Europe earlier this year but is not yet approved for use in resource-limited countries, the company said.

“Our HIV medicines are not yet included in World Health Organization (WHO) treatment guidelines for 1st- or 2nd-line treatment,” J&J said. “Nor are they part of WHO Treatment Optimization short-term objectives over the next 1-3 years. Of the three, only darunavir is currently being considered in the medium-term (4-6 years) as a possible candidate for 2nd-line treatment for adult and pediatric patients. Because WHO treatment guidelines drive the public health treatment focus and national guidelines in resource-limited countries, the current clinical demand for our medicines is extremely limited there.”

“In addition,” it said, “HIV resistance testing is not widely available in resource-limited settings, which makes the construction of active treatment regimens challenging. As a result treatment of 3rd-line patients is largely restricted to centers of excellence where physicians have specialist knowledge and/or access to resistance testing.”

J&J insists it will continue to be open to ameliorating the situation for poor patients. “We will continue to work to expand sustainable and affordable access to our HIV compounds, both as single agents and fixed-dose combinations through our 9 existing direct agreements with generic manufacturers, and future new licensing agreements,” it said. “We are also continuing to broaden the geographic reach of our agreements as we build our operational capacity to support the delivery of our HIV medicines.”

But some sources say J&J’s arrangements with generics companies are secretive and limited, for instance, to permission to repackage and distribute its product (especially in the case of etravirine and darunavir, according to MSF publication Untangling the Web – links to the three J&J antiretroviral medicines here). This is rather than allowing them to make useful formulations.

In 2010, Michel Kazatchkine, executive director of the Global Fund, wrote a letter to Jorge Bermudez, then UNITAID executive director, concerned that the price of darunavir was as much as US$ 10,000 per person per year.

J&J has a “special access price” in sub-Saharan Africa and least-developed countries for darunavir, recently announcing [pdf] that it has been lowered to US$810.30 a year. But this amounts to roughly the average annual income of people in least developed countries, and the medicine is actually more expensive as it is taken as part of regimen.

The company’s actions may be to protect future profits for their medicines in emerging markets, critics said, arguing that doctors in developing countries do not prescribe the 2nd and 3rd line treatments because they are not available there or are too expensive, a situation that would be resolved by the Medicines Patent Pool.

Wilful Harm to the Poor?

Health advocacy group Médicins Sans Frontières (MSF, Doctors without Borders) issued a statement accusing Johnson & Johnson of purposely undermining the ability of poor patients to obtain needed medicine in the name of profit.

“In saying no to the Medicines Patent Pool, Johnson & Johnson has made a conscious, willful decision to turn its back on people living with HIV in the developing world,” MSF said. “Last year, the National Institutes of Health (NIH), which holds a partial patent on the Johnson & Johnson drug darunavir, licensed its part of the darunavir patent to the Pool. By refusing to join the Patent Pool, Johnson & Johnson has effectively made this NIH license useless.”

The Pool would licence patents on HIV drugs to other manufacturers, which would lead to competition that would significantly reduce prices, “making them much more affordable in the developing world and allow[ing] new combination medicines,” MSF said.

“In refusing to join the Medicines Patent Pool, Johnson & Johnson says there is no urgency for making these drugs widely available in developing countries,” the group said “That’s simply not true.”

Patients in the United States and Europe have access to newer, better antiretrovirals that are not available in developing countries or are too expensive, MSF said, adding, “People living with HIV need access to these newer treatments.”

By combining the different drugs needed to fight AIDS into one easy-to-take pill, it is easier for patients to stick to their treatment, MSF said.

“At the moment, it can be a struggle for generic producers to develop these much needed fixed–dose combinations, because different companies own the patents on the various drugs,” it said. “By putting these patents under collective management, the Patent Pool will make it possible for many more combination therapies to be developed.”

Competition lowers prices, and individual company drug pricing discounts or deals with specific countries or generic manufacturers limit the competition, MSF said.

“Unless Johnson & Johnson and other companies take part in a collective way forward to bring affordable medicines to more people in all developing countries, they are not part of the solution as they want the public to think. They are contributing to the problem,” MSF said. “They want to control who can make and use their drugs based on their commercial needs rather than the needs of people living with HIV.”

Patent Pool Leaves Door Open

Meanwhile, the Pool said it will remain hopeful that Johnson & Johnson will have a change of heart in the future. “We don’t view this as a permanently closed door,” said Kaitlin Mara, spokesperson for the Medicines Patent Pool. “We’ll continue talking to Johnson & Johnson and we view the door as still open if they change their mind.”

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nandakumar  |  29-Jun-2013 11:28:27 IST
It is understood that the companies are not maintaining quality and they are playing with human health rigorously. Requesting FDA to review major companies quality once again to avoid such errors/ quality discepancies.
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