A top drugmaker has warned that “the government is abusing its powers” to promote drugs for people who don’t need them.
Key points:FDA chief says the drug industry is “using the government for their own profit”The government has been criticised for its “egregious” lack of transparency on how it funds researchThe company said the government has “a responsibility to make sure we can continue to have access to drugs that have been approved and are safe and effective for people”.
Drugmakers have long argued that they need to protect the public from potential side-effects from drugs they make and that they should have the right to sue the government when they feel the drugs have failed to do so.
But the US Food and Drug Administration (FDA) said in March that it would no longer allow the use of “unapproved drugs” as a way to promote them.
The agency said it would instead use the money to pay for research that would find new ways to help people avoid certain side-effect risks.
“The agency is not a regulatory agency,” FDA Commissioner Dr David Kessler told the Associated Press news agency in an interview.
“We are a regulator that has the responsibility to protect patients from the harms of drugs, so the only way we can do that is to provide them with information and access to information.”
I think what we have done over the past few years is to say, well, you can’t just put on a bunch of ads that say ‘this is the best way to get this drug to you, this is the only thing you need’, because that’s not what we’re doing.
“There’s going to be a lot of people who will be very upset and very disappointed by that.”‘
You need to be careful about how you talk to the public’Drugmakers argue that they are simply making their drugs available for people when they have no other options, and they should not have to worry about getting sued by the government if they have a serious side- effect.
“In my view, that’s what the government’s doing,” Mr Kessler said.
“And I think it’s really important that we have a system in place where the drug companies don’t have to pay to fight the regulatory agency.”
But I don’t think it is appropriate for the FDA to be in the position of saying that they’re going to defend these drugs if we say that they shouldn’t be sold.”FDA said in a statement that the government had “a long history of protecting the rights of the American people”.”
‘I feel like I’m being treated like a criminal’Drug maker says it has had to fight against a “deep and longstanding culture of fear” and “systematic misinformation” in the US drug market.'”
Our goal is to continue to make drug development more efficient and affordable while still protecting patients’ health and safety.”FDA will continue to engage in public comments, provide input to Congress, and develop regulations to ensure that Americans can access safe and affordable drugs without fear of legal action.”
‘I feel like I’m being treated like a criminal’Drug maker says it has had to fight against a “deep and longstanding culture of fear” and “systematic misinformation” in the US drug market.’
We’re doing this in good faith’The drug industry says that the lack of public scrutiny around how it makes drugs has created a culture of “misinformation” and that it is “extremely disappointed” that the FDA had not made more changes.”
This has been a huge effort,” said Gary Kildall, executive director of the Pharmaceutical Research and Manufacturers of America (PhRMA), which represents the industry.”
It’s just so disappointing to see that the public hasn’t been fully informed about what’s being done with these drugs.
“They’re not being vetted, they’re not getting tested, and in some cases, the results of these tests are not even being shared.”
The FDA says that it has received more than 12 million comments on the proposed rules and is working with stakeholders to “develop recommendations for reform”.
“I feel very confident that these are good, strong, thoughtful rules that we can and will get through Congress,” Dr Kessler said of the FDA.
“The only question is how we proceed in the future.”
One of the most important parts of this is to ensure the public has the opportunity to comment on the proposal.””
That’s why we’re working with the companies and others to help them understand how they can make this process work better.
“These are all really good, sensible, strong rules.”‘
We are not making decisions based on money’ FDA Commissioner Dr Kessler has defended the agency’s actions, saying that the agency has a responsibility to “protect the public” from risks posed by drugs they manufacture.
“As a regulator, we are not in the business of regulating drugs,” he said.
Our job is to make decisions about what are