Nullifidian
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http://www.fda.gov/bbs/topics/news/2005/NEW01259.html
Lots of FDA news lately. I won't repost the article contents, you all can click the link just as easy. I will however give some explaination of what PDUFA basically is.
PDUFA is a way by which pharma companies can pay the FDA to review their clinical data faster. The FDA has limited resources; they only have so many people to review submitted data. PDUFA allows drug companies to give the FDA money to hire contractors to speed up their review process.
There are obvious pros and cons.
Pros: you get drugs to market MUCH faster than in the past
Cons: 1) conflict of interest. Drug companies are giving money to the FDA, while not a bribe, many see it as such. Certainly however there is opportunity for misappropriation of funds.
2) It completely removes the possibility for smaller companies to compete. The FDA basically no longer reviews drugs unless you pay them to do so. While officially they do, they only have like 3 people on permanent payroll to do so because of PDUFA. Thus even if a small drug company comes out with a fantastic drug, it will never get approved unless they can fork over the hundreds of millions of dollars to the FDA for them to approve it. Thus the only way a small drug company can get a drug approved is to be bought out by a large drug company.
3) Increased cost of review process translates to increased drug cost. PDUFA contributes a lot to the increased price of drugs
On one hand, you have a policy that puts costs where they should be: on the drug companies. Rather than tax payers paying for reviewing NDAs, the drug companies pay for it. On the other hand, the consumers see this cost anyway in the form of much higher drug prices.
Personally I think it is good. While high drug prices blow, I'd rather they cost a lot than have higher taxes and fewer drugs on the market.
Lots of FDA news lately. I won't repost the article contents, you all can click the link just as easy. I will however give some explaination of what PDUFA basically is.
PDUFA is a way by which pharma companies can pay the FDA to review their clinical data faster. The FDA has limited resources; they only have so many people to review submitted data. PDUFA allows drug companies to give the FDA money to hire contractors to speed up their review process.
There are obvious pros and cons.
Pros: you get drugs to market MUCH faster than in the past
Cons: 1) conflict of interest. Drug companies are giving money to the FDA, while not a bribe, many see it as such. Certainly however there is opportunity for misappropriation of funds.
2) It completely removes the possibility for smaller companies to compete. The FDA basically no longer reviews drugs unless you pay them to do so. While officially they do, they only have like 3 people on permanent payroll to do so because of PDUFA. Thus even if a small drug company comes out with a fantastic drug, it will never get approved unless they can fork over the hundreds of millions of dollars to the FDA for them to approve it. Thus the only way a small drug company can get a drug approved is to be bought out by a large drug company.
3) Increased cost of review process translates to increased drug cost. PDUFA contributes a lot to the increased price of drugs
On one hand, you have a policy that puts costs where they should be: on the drug companies. Rather than tax payers paying for reviewing NDAs, the drug companies pay for it. On the other hand, the consumers see this cost anyway in the form of much higher drug prices.
Personally I think it is good. While high drug prices blow, I'd rather they cost a lot than have higher taxes and fewer drugs on the market.
