"Science" continuously issued a document to refer to the FDA drug approval of the money transaction
The US FDA, considered to be the most impartial and authoritative new drug approval agency in the world, is welcoming a crisis of confidence.
Recently, Science magazine published two articles directly referring to FDA approval and “thinking†transactions between pharmaceutical companies, including a hidden conflict? The article states that although there are few recognized and unapproved potential conflicts of interest in the FDA's new drug review advisory panel, some members will receive approval from the drug manufacturer under review or after the drug review is completed. The opponent's large sum of money, and this "post-paid" type of financial association is rarely found and has never been supervised.
The article also begins with a scenario in which: 8 months ago, in July 2010, in a hotel in Maryland, a review team consisting of eight reviewers (7 medical experts and 1 patient representative), A new cardiovascular drug is being reviewed. The work done by this group of auditors is the daily work of dozens of FDA audit teams. The audit work has been carried out without hesitation. The auditors have politely asked questions from the pharmaceutical companies who have been reviewing the trials. They also compliment them from time to time. The results of the research, in the end, the new drug was voted by the auditors with a huge advantage of 7-1, after the listing, it sold 25 times higher than the main competitor. After the investigation, it was found that after the drug was listed, 4 of the 7 medical experts accepted the “sponsorship†from the pharmaceutical company, but this is not a case.
It is understood that according to the analysis of the records of the US Federal Public Payments website from 2013 to 2016, it is found that among the 107 experts who served as FDA's new drug review consultants during this period, 40 people later came from new drug manufacturing companies or their competition. The opponents obtained more than 10,000 US dollars of funds, of which 26 consultants obtained more than 100,000 US dollars after the event, and 7 more profited more than 1 million US dollars. The 17 most-funded consultants received more than $26 million in funding, 94% of which came from drug manufacturers or their competitors previously reviewed by these consultants. In one of the examples cited in the survey, a doctor was found He has received more than $200,000 in travel, honors and consulting fees from pharmaceutical companies and competing companies that voted for a drug.
At the same time, the survey also showed that these people not only benefited from pharmaceutical companies afterwards, but also many people received financial support from pharmaceutical companies during the first year of consulting services for the FDA.
In addition, Science also mentioned another problem that is difficult to digitize. Among the 16 FDA medical auditors who have reviewed 28 drugs in total, 11 have resigned to the drug companies approved by them, BMJ. The same problem was mentioned in a survey in 2016.
In the interview with some medical experts who received funds from the pharmaceutical companies in the later period of Science, they very convinced the fact that most of these funds were “car and horse feesâ€, “research feesâ€, “reward moneyâ€, and “consultationâ€. The name of the fee has flowed into their pockets. However, some medical experts said that this kind of interest relationship is a professional performance and acknowledges that expecting benefits in the future will indeed lead to bias in approval.
Some industry insiders pointed out that the reason for this is because the FDA does not have a system for identifying whether the members of the newly approved drug review advisory team are financially related to the pharmaceutical company, although it will require the review panel members to disclose their financial affairs with the pharmaceutical company in advance. Relationships, and must prove the authenticity and completeness of the information provided. FDA will use these disclosures to determine their eligibility to participate in the review. Sometimes, FDA will also provide exemptions to some conflicting parties, so as not to affect their eligibility. Approved. However, Science pointed out that this review process relies on a system of integrity and misses many obvious financial connections.
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