By now you’ve probably heard that a number of major US pharmaceutical companies have been forced to admit to having been unable to obtain a ‘preclinical approval’ for drugs.
There are plenty of examples of pharma firms failing to obtain ‘pre-clinical approval’, but here are just a few: Pharma giant AstraZeneca (NASDAQ:AZN) was forced to cough up $2.5 billion for the first time to secure approval to use its novel COVID-19 vaccine in the United States.
The US Food and Drug Administration (FDA) has previously denied the company’s claims that it had not been able ‘to obtain FDA preclinical approval for the vaccines’ in 2017.
And in 2019, Pharmaceutical giant Bristol-Myers Squibb (NASDAQ :BMY) also admitted to not being able to secure pre-clinical approvals for the drugs COVID-20 and COV-9.
In February 2018, Bristol-Myrs Squibbs declared that it was unable to secure a pre-trial approval of its COVID vaccines for use in the US.
Brunson-Koch (NYSE:K) found itself facing similar pressure when it announced that it would not be able to access pre-market approval for an HIV vaccine in 2018, despite having secured a patent in the US.
As part of the bailout package, Koch announced that it will spend up to $2 billion on a ‘technology and innovation fund’ to accelerate its vaccine development programme.
It will also spend $1 billion on additional research and development to help ensure its vaccines reach more people and increase their efficacy.
However, as Bloomberg reported in 2018, ‘The fund will likely be taken up by the U.S. pharmaceutical company Pfizer Inc., which had asked for a preclinical-approval waiver from the FDA to get its HIV vaccine for sale in the U.K. in January 2018.’
The FDA has since granted the drug company a waiver to start marketing the vaccine in England and Wales.
As of September 2018, Pfizer had already secured a provisional license to distribute the vaccine, which it will now have to apply for a final approval to distribute it in the UK.
Another drug company, Johnson & Johnson (NYSE:JNJ), announced in October 2018 that it had failed to obtain pre-registration for its copper-based drug Adriamycin.
According to the European Medicines Agency, Johnson’s COVID vaccine has only been available in the European Union for five years.
Johnson also said that it has received a waiver from UK authorities to start distributing its COV-19 treatment in the country.
This was confirmed by the British government’s Investigatory Powers Commissioner earlier this year.
Also in October, Johnson &.; Johnson was forced to pay a fine of $50 million after it was revealed that it failed to secure ‘premarket approval’ to distribute a COVID drug.
Despite having been forced into the UK, the drug company did not submit a detailed plan for how it would distribute the drug in the future, leaving many experts to conclude that Johnson may not be as keen on selling its drug to the UK as the company had stated it was.
While Pharisa Pharmaceuticals (OTCPK:PHAR) made headlines in October when it announced that its COVI vaccine was failing to obtain the pre-market approvals it needed, a spokesperson told the BBC that it ‘does not disclose the final number of preclinical approvals required for a product before it is available for clinical trials.’
In December 2018, Johnson& the UK government said that it had ‘not received a final preclinical license for its COVI vaccine’.
The government also stated that the company had not received a provisional pre-regulation approval from the US Food and Drugs Administration (USFDA).
In addition, Pfizer and Johnson&s; Johnson both declined to disclose how much money they were spending on research and research development for their COVID drugs, despite the fact that they were already in the process of applying for FDA approval.
Pharrisa’s founder David Krasner said in January that there was ‘no way’ that Pharcisa could afford to pay for a pre-order for a vaccine.
‘We will never