In one week the FDA has been pilloried as being to ineffectual in the effort to make medicines safer and now, in a New York Times article, described as an agency under seige too afraid to approve any new medication in a timely fashion. Has anyone ever written an article commending FDA employees for just doing a good job on behalf of the public health?
The fact is while there are some reviewers and senior officials who are likely to be cautious most people working in the FDA are truly devoted to the public health and have no ax to grind against drug companies.
The fact is, most folks at the FDA -- like those at the drug companies -- know a good drug when they see it and work hard -- without bending rules to make sure a medicine gets a fair shot at approval. To be sure no one at the FDA is going to break new scientific ground in terms of establishing endpoints but the agency is, despite IT limitations, still the single largest repository of information on how to measure the relative risks and benefits of medicines on earth. Which means that they are fairly good, if not always up to date, on how they do their jobs.
The bottom line, at least in 2005, was a reflection of continued effort to use the regulatory tools at hand to make medicines available as quickly as possible. Have there been demands for additional data before going to market? Absolutely. And in some cases companies have volunteered the data while in others the requests are probably better obtained post market through observational studies. But in the main, the demands for data are not all that onerous.
Moreover, if you look at the nature of the medicines approved, they reflect a desire to understand if the risk-safety profile will apply in subpopulations that are likley to receive entirely new medicines.
On the whole, the debate too fast/too slow debate about the FDA has grown tired, empty and irrelevant. The real issue is, will the media and politicos focus on what the agency needs to move drug approvals into personalized and targeted era? Meanwhile, an overview of the accomplishments of Center for Drug Evaluation and Review -- hardly mentioned in the media -- are listed below... And by the way, thanks for your efforts...
Many Americans benefited from last year’s timely reviews of new prescription medicines, over-the-counter medicines and the generic equivalents for both. When we review a medicine, we use the best science available to determine if a medicine’s benefits outweigh its risks for its intended use. An internal study showed that about half of our professional staff time is spent on safety assessment. We oversee the development of new medicines in the United States, and our paramount concern is the safety of patient volunteers in clinical trials.
Highlights for 2005 include:
* 80 new medicines. We approved 78 drugs and two biologics (22 priority and 58 standard reviews).
* 20 truly new medicines. We approved 18 drugs and two new biologics that had never been marketed before in any form in this country (15 priority and 5 standard reviews).
* 141 new treatment options. We approved new or expanded uses for 126 already approved drugs and 15 already approved biologics (36 priority and 105 standard reviews).
* 5 over-the-counter drugs. Our approvals included five new medicines to be sold over the counter without a prescription, and four of them can be used by children. We approved three new uses for existing OTCs, all of which can be used by children.
* 10 “orphan†medicines. Our approvals included nine drugs and one biologic for patient populations of 200,000 or fewer.
* 344 generic drugs. We gave final approval to 344 generic versions of existing drugs and tentative approval to another 108. We received 777 marketing applications for generic drugs.
* User fee goals. We exceeded all our performance goals for the fiscal year 2004 receipt cohort, the latest year for which we have full statistics. We are on track for exceeding most user-fee performance goals for the fiscal year 2005 cohort.
The fact is while there are some reviewers and senior officials who are likely to be cautious most people working in the FDA are truly devoted to the public health and have no ax to grind against drug companies.
The fact is, most folks at the FDA -- like those at the drug companies -- know a good drug when they see it and work hard -- without bending rules to make sure a medicine gets a fair shot at approval. To be sure no one at the FDA is going to break new scientific ground in terms of establishing endpoints but the agency is, despite IT limitations, still the single largest repository of information on how to measure the relative risks and benefits of medicines on earth. Which means that they are fairly good, if not always up to date, on how they do their jobs.
The bottom line, at least in 2005, was a reflection of continued effort to use the regulatory tools at hand to make medicines available as quickly as possible. Have there been demands for additional data before going to market? Absolutely. And in some cases companies have volunteered the data while in others the requests are probably better obtained post market through observational studies. But in the main, the demands for data are not all that onerous.
Moreover, if you look at the nature of the medicines approved, they reflect a desire to understand if the risk-safety profile will apply in subpopulations that are likley to receive entirely new medicines.
On the whole, the debate too fast/too slow debate about the FDA has grown tired, empty and irrelevant. The real issue is, will the media and politicos focus on what the agency needs to move drug approvals into personalized and targeted era? Meanwhile, an overview of the accomplishments of Center for Drug Evaluation and Review -- hardly mentioned in the media -- are listed below... And by the way, thanks for your efforts...
Many Americans benefited from last year’s timely reviews of new prescription medicines, over-the-counter medicines and the generic equivalents for both. When we review a medicine, we use the best science available to determine if a medicine’s benefits outweigh its risks for its intended use. An internal study showed that about half of our professional staff time is spent on safety assessment. We oversee the development of new medicines in the United States, and our paramount concern is the safety of patient volunteers in clinical trials.
Highlights for 2005 include:
* 80 new medicines. We approved 78 drugs and two biologics (22 priority and 58 standard reviews).
* 20 truly new medicines. We approved 18 drugs and two new biologics that had never been marketed before in any form in this country (15 priority and 5 standard reviews).
* 141 new treatment options. We approved new or expanded uses for 126 already approved drugs and 15 already approved biologics (36 priority and 105 standard reviews).
* 5 over-the-counter drugs. Our approvals included five new medicines to be sold over the counter without a prescription, and four of them can be used by children. We approved three new uses for existing OTCs, all of which can be used by children.
* 10 “orphan†medicines. Our approvals included nine drugs and one biologic for patient populations of 200,000 or fewer.
* 344 generic drugs. We gave final approval to 344 generic versions of existing drugs and tentative approval to another 108. We received 777 marketing applications for generic drugs.
* User fee goals. We exceeded all our performance goals for the fiscal year 2004 receipt cohort, the latest year for which we have full statistics. We are on track for exceeding most user-fee performance goals for the fiscal year 2005 cohort.
