Looks like the NY AG is attempting to close down the pharmas that produce opiate medications. All FDA approved medication is done so via a (NDA) new drug application… and it is not clear if the pharma that has a NDA on a medication has a liability tail , even if they are no longer producing the specific medication… BUT… generics are produced under a ANDA ( Abbreviated New Drug Application). Which links the generic med to the brand name med and the Pharma that discovered and owns the NDA for that brand name. Will these pharmas that still “own” the NDA for a medication… will the brand name pharma be considered indirectly manufacturing opiates because of the link between the NDA and ANDA ? Could the brand name pharma be sued because they still own the NDA which allows other pharmas to manufacture generic of the brand name meds ? J&J and their subsidiary Jansen who manufactured Duragesic patch… the last lot of Duragesic patches produced has a expiration date of JULY 31, 2021… SO.. there is no longer any Duragesic patches available, but as long as there is a valid NDA… generic pharmas can have or seek to have a ANDA. Could these anti-opiate attorneys… go after all the pharmas that own NDA’s on opiates and sue them in court and get them to agree that they are getting out of the opiate business but then go back after these same companies and claim that unless they rescind/revoke their NDA’s… they may go after those same pharmas AGAIN… claiming that those pharmas are “still in the opiate business”… Could these pharmas with NDA’s end up selling the NDA to a foreign pharma and all of our opiates will be produced over seas… Of course, if all our brand name pharmas are out of the opiate business… who is going to do any R&D on any ‘non addicting” new opiates ?
Johnson & Johnson confirms opioid business has ended in $230 million settlement with New York
- New York Attorney General’s office said the agreement bans J&J from promoting opioids through any means and prohibits lobbying about such products at the federal, state or local levels.
- However, Johnson & Johnson said it had already exited the business.
- As part of the settlement, the company will resolve opioids-related claims and allocate payments over nine years.
- The settlement follows years of lawsuits by states, cities and counties against major pharmaceutical companies over the opioid crisis, which has killed nearly 500,000 people in the U.S. since 1999.
Johnson & Johnson has agreed to a $230 million settlement with New York state that bars the company from promoting opioids and confirmed it has ended distribution of such products within the United States.
New York Attorney General Letitia James’ office in a statement Saturday said the agreement bans J&J from promoting opioids through any means and prohibits lobbying about such products at the federal, state or local levels.
Johnson & Johnson has not marketed opioids in the U.S. since 2015 and fully discontinued the business in 2020.
As part of the settlement, the company will resolve opioids-related claims and allocate payments over nine years. It could also pay $30 million more in the first year if the state executive chamber signs into law new legislation creating an opioid settlement fund, according to the press release from James’ office.
The settlement follows years of lawsuits by states, cities and counties against major pharmaceutical companies over the opioid crisis, which has killed nearly 500,000 people in the U.S. in the last couple decades.
Governments have argued that companies over-prescribed the drugs, causing people to become addicted and abuse other illegal forms of opioids, while companies have said they’ve distributed the necessary amount of the product to help people with medical issues.
“The opioid epidemic has wreaked havoc on countless communities across New York state and the rest of the nation, leaving millions still addicted to dangerous and deadly opioids,” James said in a statement.
“Johnson & Johnson helped fuel this fire, but today they’re committing to leaving the opioid business — not only in New York, but across the entire country,” she said.
“Opioids will no longer be manufactured or sold in the United States by J&J.”
The New York opioid lawsuit trial against the rest of the defendants will begin this week, according to the release. Other defendants in the New York suit include Purdue Pharma; Mallinckrodt LLC; Endo Health Solutions; Teva Pharmaceuticals USA; and Allergan Finance LLC.
In a statement Saturday, Johnson & Johnson said the settlement “is not an admission of liability or wrongdoing by the company” and is “consistent with the terms of the previously announced $5 billion all-in settlement agreement in principle for the resolution of opioid lawsuits and claims by states, cities, counties and tribal governments.”
The company also said it would continue to defend against any lawsuits the final agreement does not resolve.
James said the state will focus on funding for opioid prevention, treatment and education efforts in order to “prevent any future devastation.”
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