The IN VIVO Blog: Another Dismal Year for New Drug Approvals:

Where have all the new drug’s gone: Industry’s medicine cabinet running empty on compounds- NJ.com

With only 18 approvals it is the lowest since 1983 when there were only 14. The FDA says final figures won’t come out until March but even then most of us think the total will likely not be any higher than 19. While there seem to be a lot of theories as to why this is the case, I don’t think there is any one singular explanation. I personally think it is a combination of the FDA being more cautious (although the FDA denies this and says there has been no policy change) and the fact that all the low lying fruit has been picked and it is indeed much harder now to find new and innovative therapies.

I do believe that some of the recent breakthroughs in basic research such as the human genome will eventually lead to new drug discoveries but that one of the primary issues is everyone under estimates how long it takes to go from basic research to commercial application, especially in the drug industry. This is one of the primary mind traps that everyone falls into in all industries but it seems to be exaggerated in the pharmaceutical industry.

I’m not sure what will help the situation and I’m not confident it will turn around soon. I am confident that in the long run, the issue will be resolved. I just hope it doesn’t take too long.

Technorati Tags: drug approval, FDA

PharmaLive: Pfizer Receives Approvable Letter from FDA for Dalbavancin :

Basically the FDA wants more evidence regarding non-inferiority as the basis for approval.

I personally think that antibiotics is NOT an area where the FDA needs to be seen as holding things up. With the rising number of MRSA infections occurring even outside the hospital the need for new antibiotics is growing and will continue to grow. Having been affected by this personally and knowing that only vancamycin worked in that case the need for new antibiotics will continue to be of concern.

Technorati Tags: dalbavancin, FDA, Pfizer

The FDA: Caught between a rock and a hard place - FierceBiotech

I can understand the FDA reacting to recent situations such as Vioxx but they do indeed seem to be sending a mixed message; emphasizing the need for speeding drugs to market but then seeming to have set a higher standard. THe FDA says therre jave been no policy changes but the fact that only 15 new drugs were approved in 2007 seems to indicate otherwise.

I just hope that we can have a open and honest discussion about risk management and acknowledge that all drugs have risk and many times that full impact of that will not be determined until after the drug has gone on the market.

Technorati Tags: drug approval, FDA

Glaxo set to axe staff as crisis hits drug - Telegraph
Generic Biotech Drugs Won’t Be in U.S. Legislation Bloomberg.com: News
The Scientist : New patent rules hurt biotech?
Chemical & Engineering News: Government & Policy - Patent Reform Inches Ahead
AstraZeneca to outsource manufacturing - Times Online
AstraZeneca To Outsource Drug Manufacturing - Contract Pharma
StockHouse.com : Encysive Pharmaceuticals Receives Written Response From FDA On
Cephalon warns over pain drug deaths| Reuters
PharmaLive: Adverse Drug Events Reported to FDA Appear to Have Increased Markedly
Sanofi-Aventis Developing New Drugs: Financial News - Yahoo!
Finance
House Passes Bill to Improve Drug Safety: Financial News - Yahoo!
Finance
Senate OKs FDA drug safety bill - washingtonpost.com
Many drugs slip through regulatory ‘black hole’ - CNN.com
Bristol-Myers to buy partner Adnexus for $430 million”>SignOnSanDiego.com >
Warning issued on Cephalon painkiller | Philadelphia Inquirer | 09/27/2007

My overall observations is that there are many factors influencing the pharma industry today and these are not likely to less anytime in the near future. It would be nice to see more positive articles but those seem to be hard to come by in the current environment.

Technorati Tags: Adnexus, AstraZeneca, Bristol-Myers Squibb, Cephalon, Encysive, FDA, Glaxo, GlaxoSmithKline, Sanofi-Aventis

UPDATE 1-Lawmakers: Generic biologics unlikely in FDA bill | Health | Reuters

I personally think there should be something at least giving a timeframe on when the FDA should have to present a report to Congress on how and when they will implement some kind of program.

Here is the key from my perspective.

The chances of adding the generic biologics measure to a broad FDA bill now moving through Congress are “extremely slim,” Rep. Henry Waxman, a California Democrat, told a Generic Pharmaceutical Association conference.

I realize that biologics are not like standard drugs in terms of generics but really think that until Congress demands that the FDA come up with some sort of plan, nothing will move forward. It is too bad that Europe will be the one taking the forefront in this movement. As an example, EMEA just approved a follow-on for EPO for Sandoz, Novartis’ generics division.

Sandoz Receives European Commission Approval for biosimilar epoetin alfa

I know there will be a lot of lobbying of Congress on this issue but think that regardless there needs to be some sort of plan put forward. Just trying to delay and avoid the issue is only going to cause more public relations problems for biotech in the future.

Other Recent Stories Related to Biogenerics

Biotech firms will soon lose patent protection - Sep. 5, 2007
Lawmakers Offer U.S. Plan for Generic Biotech Drugs
RED HERRING | Going Generic
Follow-on biologics ‘not substitutable’, says BIO
Biopharmaceuticals | Follow-on Biologics: Friend or Foe? | Pharmaceutical Manufacturing
Patent Baristas » Senate Committee Approves Follow-On Biologics Bill: Fear and Trepidation Follow
Biologics Price Competition and Innovation Act of 2007 (S. 1695)

Technorati Tags: biogenerics, biosimilars, FDA, follow-on biologics

Dr. Reddy’s Gets Generic Ambien Approval - Forbes.com:

I was actually behind someone at my local pharmacy recently and they were concerned they thought they had been given the wrong prescription since they did not recognize the name. The pharmacist explained that it was the generic version of Ambien. This could be a big blow to Sanofi-Aventis since they had sales of $1.2 billion in the last year.

While Dr. Reddy’s Lab is the first, there will be several others and the competition will bring down the price. At least 10 other companies have approved generic versions.

Both my wife and I use it on occasion and I love it. I especially use it when traveling to get my body in sync with the local time. I should note that it has recently come under scrutiny and the labeling has been strengthened to warn about possible side effects.

Technorati Tags: Ambien, Sanofi-Aventis, zolpidem tartrate

Dr. Reddy’s Gets Generic Ambien Approval - Forbes.com:

I was actually behind someone at my local pharmacy recently and they were concerned they thought they had been given the wrong prescription since they did not recognize the name. The pharmacist explained that it was the generic version of Ambien. This could be a big blow to Sanofi-Aventis since they had sales of $1.2 billion in the last year.

While Dr. Reddy’s Lab is the first, there will be several others and the competition will bring down the price. At least 10 other companies have approved generic versions.

Both my wife and I use it on occasion and I love it. I especially use it when traveling to get my body in sync with the local time. I should note that it has recently come under scrutiny and the labeling has been strengthened to warn about possible side effects.

Technorati Tags: Ambien, zolpidem tartrate, Sanofi-Aventis

FDA Rejects Merck’s Vioxx Successor - Forbes.com:

It is interesting to note though that Arrcoxia is on sale in 63 countries world-wide already. It be be interesting to see what effect if any it has on world-wide sales.

Technorati Tags: Arcoxia, Merck, Vioxx

Drug Safety | The Harmful Side Effect We Never Hear About / Congressional Cures? | Pharmaceutical Manufacturing:

I reported recently about drug safety and establishing database and this article has even more details. I highly recommend these two articles article. They were written by Dr. Henry I. Miller of the Hoover Institution. He is an ex-FDA who worked at the administration from 1979 until 1993 and was one of the founding directors of the Office of Biotechnology at the FDA where he served as head from 1989-1993. The first is about harmful side effects of drugs and the mismanagement at the FDA and the second deals legislation currently before Congress. I highly recommend both of these articles.

Technorati Tags: drug safety, FDA

Expert Questions Import Drug Savings - washingtonpost.com

Stephen Schondelmeyer, a University of Minnesota pharmaceutical economist testified that imports would cut U.S. prices by only 12 percent to 20 percent (emphasis mine). I’m not sure what this economist think is significant but for many people on fixed incomes who are paying hundreds or dollars (or more) each month for prescription drugs this is indeed significant! I think it may again be a case of someone in an ivory tower not being in touch with some of the concerns of normal everyday people.

As regular readers know though, this doesn’t mean I favor drug imports. I also don’t think the safety issue usually raised is insurmountable, but it would be costly and I doubt congress would increase the FDA budget enough to allow it to do this job thoroughly and safely. My disfavor of this approach is simply based on populations of the listed countries. Usually this list includes Canada, New Zealand, Australia and some European countries (but never specifically identified).

Excluding Europe for now (I’ll comment on that below) these other countries are so small in population that the US, if even a small percentage of people imported drugs, it would easily strip them of their supplies. Also, some drug companies have already stated that if this occurs, they will only sell certain amounts of drugs to these countries and they would have to decide whether to sell them to their own people or export them to the US but that the drug companies would not allow the purchase of huge amounts of drugs just so those countries could export them to the US.

It should also be noted that in Europe, drug companies must negotiate prices directly with the government since in most cases they are the sole healthcare provider (this could be looked at as another reason why the US should seriously consider universal healthcare, but that’s another subject for another time). If you ask people on the street here in the US if they favor price controls on drugs, most will say no. However, this is basically what would occur. Importing drugs from Europe would essentially be saying we agree with the price controls of foreign governments. If we truly believe that, then why not just pass legislation with price controls tied to those in Europe?

My larger concern is that Congress has a history of giving the FDA additional responsibility but has not given them an increase in funding to achieve those responsibilities. They are already underfunded by most experts estimates and setting up a new system to deal with drug imports would be costly at least at first. Then there are other issues Congress wants the FDA to deal with such as biogenerics and a drug safety database. This is one of the reasons I favor giving the FDA powers similar to the EPA of fining drug companies for infractions of the rules.

The bill being discussed is S424 (S. 242–110th Congress (2007): Pharmaceutical Market Access and Drug Safety Act of 2007

Technorati Tags: drug cost, drug imports, drug price

Caution urged on biologic drugs - The Boston Globe

Europe has had biogenerics for the last four years but European regulators have required human clinical trials for these products. I think there is need for talking about what process may be in the best interest of patients and is safe. I’d like to see criteria developed for biologics that would allow it to be determined which can be safely approved in a fashion similar to the current generics model based on bioequivalence, and which would have to undergo human trials. I don’t fall into the trap that some do of insisting it is either one or the other. However I think it may be difficult to draw up guidelines for determining which track a given product should follow that a majority will agree with. That doesn’t mean it can’t happen, but it will be contentious.

Technorati Tags: biogenerics, FDA

FDA Drug Safety Podcasts

While I find it refreshing that they would do these (and they also provide transcript by the way) it seems that only a few minutes is too short to convey any really useful information. Also, they have a lot to learn about how to do podcasting and making it successful.

It sounds unnatural and stilted. I’m sure they are just reading a script as there in no intonation or dynamics at all. They also need to learn proper mic technique to get rid of popping p’s and hissing s’s. I could barely get through the seven minutes without nodding off due to the monotone nature of the podcast.

While I find it promising they are taking advantage of a new technology, I certainly wish they would have done more to learn about it before putting together such as poorly produced product.

Technorati Tags: drug safety, FDA, podcast

Report: FDA Eyes Kids’ Cold Drugs - Forbes.com
Warnings sought on kids’ cold medicine - Yahoo! News

The cause of this was a filing by Baltimore health authorities and others yesterday (Mar 1, 2007). A recent report from the Center for Disease Control that noted 1,500 toddlers and babies had been taken to the emergency room because of over the counter cough and cold remedies over a two year period. And the medical examiner in Baltimore noted that at least four children under the age of four have had their deaths linked to these products over a five year period.

None of these products are recommended for children younger than two and all state that it should not be used except under the advice of your doctor. But the report says that many products contain the name “infant” or “baby” such as “baby aspirin”. These along with pictures of mothers holding infants and other children much younger than two are shown in the packaging.

I personally think the warnings are adequate but that some of the pictures and wordings in the packaging should be changed so as to not be misleading. I’d like to see the OTC industry do this voluntarily but I don’t think that will happen. And I don’t think the FDA is likely to step in and require that. It is much more likely in my opinion for the FDA to issue a statement saying that these products should not be used in children younger than two without instruction from their doctor.

This does bring up the bigger issue of how do you determining the proper dosing of these OTC products in children? Most data is from extrapolation of adult data and may not be appropriate to children. THis is really the bigger question and one for which there is no answer currently.

Technorati Tags: drug safety, pediatric drugs

Sanofi Gets Nod From FDA Panel:
Sanofi Bird-Flu Shot’s Benefit Isn’t Clear, FDA Says

I would comment that vaccination are not 100% effective in all cases. I know from painful experience that this is the case. When I was young I was given a attenuated live vaccine for measles along with gamma globulin. Then as an adolescent, I developed full blown measles.

However to help prevent a pandemic, 100% effectiveness is not necessary. It is only necessary to vaccine a critical number of folks that will help prevent the spread of the disease. Right now, I think that this particular vaccine is not worth the risk unless you happen to be a chicken farmer. No one in the US has ever developed bird flu and right now it is difficult to spread from human to human. There have only been 270 cases in 10 countries world-wide. An interesting comment in the article is that this vaccine will NOT be commercially available and that governments will likely stockpile it to protect first responders and healthcare workers if needed.

Technorati Tags: bird flu, vaccine

FDA cuts food inspections by half

They report that over the last three years, food safety inspections have dropped in half! Here are some other startling facts from their investigation:

- There are 12 percent fewer FDA employees in field offices who concentrate on food issues.
- Safety tests for U.S.-produced food have dropped nearly 75 percent, from 9,748 in 2003 to 2,455 last year, according to the agency’s own statistics.

After Sept 11, 2001 the FDA urged increasing food inspection and that did indeed happen and peaked in 2003 but have fallen back and erased those gains.

I have stated before that given the number of high profile cases in the last year, there will be increased scrutiny in this area, especially from Congress. I would not at all be surprised by a hearing on this sometime before the summer. The problem is, there are many other areas of higher priority now such as the war in Iraq.

The budget for next year does include modest gains for food safety of $10.6 million, but most critics agree this is only a very small portion of what is really needed to do their job properly. Some claim that as much as ten times that amount would be necessary.

The FDA Commissioner had his to say.

“We’re applying resources to targeted areas. So in a way, it’s not a matter of ‘Are you inspecting one out of 100 or 10 out of 100?’ The real issue is if you can define risk. Are you applying the 10 inspectors to the 10 areas of concern? Then it’s essentially you’re covering 100 percent of your problem, which is not covering 100 percent of the universe,” FDA commissioner Dr. Andrew von Eschenbach said.

While this is a good goal and I am a advocate of risk based assessment, it ignores the fact that some risks exist that we do not know about. In the case of the lettuce e.coli problems it may be that a feral pig defecated in the field and that was the source of the contamination. I doubt anyone would have had that on their list of criteria for risk assessment.

Technorati Tags: FDA inspection, food safety

Former FDA chief fined $89,377 - Feb. 27, 2007

Boy did I get this wrong. You may remember I made a prediction back in October that said he would be fined $10,000 and given 2-3 months probation. This was based upon my pessimistic view of high level officials ever being truly held accountable. I am glad to see that the judge thought this was worthy of more punishment than that. It is interesting that the fine is much larger than the agreed amount of $50,000 between Crawford and the prosecutor, but still lower than what could have been handed down.

I personally would like to have seen more hours of community service given out. Fifty hours is just slightly more than one work week.

Technorati Tags: FDA, FDA Commissioner

Press Release: FDA Approves Eli Lilly and Company Cymbalta - FierceBiotech:

This brings to three the number of indications for this drug. The others include depression and diabetic neuropathy.

Technorati Tags: drug approval, Eli Lilly, Cymbalta

FDA approves Shire’s ADHD drug Vyvanse - Yahoo! News:

Here’s the Shire press release. This is big for them and for anyone suffering from ADHD. This drug seems to be better tolerated and longer lasting than other stimulates used to treat this disorder.

Other Resources

lisdexamfetamine dimesylate - Yahoo! Search Results
lisdexamfetamine dimesylate - Google Search
Google Blog Search: lisdexamfetamine dimesylate

Technorati Tags: lisdexamfetamine dimesylate, Vyvanse

FDA experts to vote on America’s first bird flu vaccine - Feb. 23, 2007:

It will be interesting to see what comes out of this meeting. I still think that the concerns over bird flu are currently overstated. Many more will die this year from the standard flu than from bird flu.

As the article point out though, it is impossible to develop a precise vaccine against bird flu unless it actually mutates into a pandemic strain. It is a difficult decision to stockpile a vaccine that may likely do no good whatsoever. However, it is also unconscionable to do nothing. I think the best spending of money would be on technologies that get away from using chicken eggs to produce vaccines. The way the pharmaceutical industry produces vaccines has not changes in many, many years. If bird flu should become epidemic within the chicken population and not affect humans directly, it could still have a major impact on humans since ALL vaccines are made using chicken eggs. This would inhibit the ability to produce any other vaccines. These technologies, if they allowed rapid ramp up of production, could easily be used for other vaccines in the future.

Technorati Tags: bird flu, FDA, Sanofi-Aventis, vaccine

Prescription Drugs | Prescription Drug Makers Have Not Begun Many Pending Post-Market Studies on Newly Approved Drugs, FDA Says - Kaisernetwork.org:

Here is the latest numbers for 2006 from the FDA: Postmarketing Study Commitments 2006 [HTML] [PDF ]

These are studies that pharmaceutical companies agree to as a condition for approval of the drug. The problem is, the FDA has no authority to do anything if companies do not comply. Their only true recourse is to withdrawal approval but that is something they have never done for failure to complete post-marketig studies. It isn’t something I would recommend either as it would hurt too many patients who may truly need a specific drug.

Some in the industry complain that it is hard to recruit patients for some drugs. That may very well be the case, but that doesn’t mean they should not even start trials. It means it may take longer to get them completed. However, that reasoning does not address the extremely high percentage of studies that have not even been started! Also, if there will be a problem getting patients for these studies, then the companies should discuss that with the FDA at the approval and agree to start them but state that it will likely take longer to complete them. It would be interesting to try and determine how many drugs pharmaceutical companies make this sort of claim for and look at how many prescriptions are written for those drugs. One of the problems is, someone in a phase IV study (aka post-marketing studies) will not be generating revenue for the company.

At the heart is the fact that these studies tend to be large and costly and in most cases, the companies will not be achieving anything substantial from them (i.e. a competitive or marketing advantage). They are mainly studies to give the FDA better confidence in the safety of the drug. Therefore, from a strictly business perspective (ignoring safety), it makes sense to put off these trials as long as possible since they are costly and are not likely to bring any benefit for the companies. Also, if there are no consequences than why do them? I would argue that sort of mentality is very shortsighted and not including the potential costs of later legal problems if the drug should have some unintended consequences (i.e. Vioxx).

Also, if this sort of trend continues, there will certainly be more power given to the FDA. I have always found it interesting that the EPA can fine companies in order to protect the environment (and the potential human consequences) but the FDA has no such power to fine companies for failing to complete required pot-marketing studies that have a larger potential to do harm.

Fro another view see Opinion | Delayed FDA Post-Marketing Study Statistics ‘Misrepresented,’ Opinion Piece Says - Kaisernetwork.org

Other Resources (note: some are from 2005)

FDA says too many drug studies delayed - Boston.com
FDA Accused of Dropping the Ball on Post-Marketing Studies of Fast Track Drugs - CME Teaching Brief® - MedPage Today
FDA To Drug Firms: You Promised, Where Are The Post-Marketing Studies? - CBS News
Postmarketing Study Commitments Database (FDA website)
Postmarketing Study Commitments: Introduction (FDA website)

Technorati Tags: FDA, post-marketing studies, phase IV studies

Amid Doubts, FDA Makes Case for More User Fees (FDA Webview)

I still find it interesting that they loudly proclaim that it doesn’t influence their decisions. This runs counter to the Institute of Medicine report.

Assessment of the U. S. Drug Safety System - Institute of Medicine

And here is the actual report:

The Future of Drug Safety: Promoting and Protecting the Health of the Public

Here is the pertinent section of the IOM report:

An agency whose crucial mission is to protect and advance the public’s health should have adequate resources to do its job. Also, the effect on CDER’s work of CDER’s overdependence on PDUFAfunding with restrictions on how FDA can use the money from user fees hurts FDA’s credibility and may affect the agency’s effectiveness.

To support improvements in drug safety and efficacy activities over a product’s lifecycle, the committee recommends that the Administration should request and Congress should approve substantially increased resources in both funds and personnel for FDA. The committee favors appropriations from general revenues, rather than user fees, to support the full spectrum of new drug safety responsibilities proposed in this report.

I firmly believe that Congress needs to address the funding situation and would like to see the FDA given a reasonable budget and not have them rely on creative funding sources. While it may not actually affect their decisions, I think that even the appearance of conflicts should be avoided given how important the FDA’s job is and how it effects everyones daily lives.

Technorati Tags: drug safety, FDA

Pharmacyclics: FDA Won’t Take Filing - Forbes.com:

The stock dropped 46% on the news and is definitely bad news. The FDA said there was not enough in the filings to bother with a substantial review and that too many clinical trials had failed to show statistically significant differences from between treatment arms. This leads me to wonder who is heading up the regulatory group as this sort of situation should never be allowed to happen.

Looking up refuse to file I found that Imclone received one back on Jan 2002 over Erbitux.

Pharmacyclics had a webcast conference call yesterday and is available for one month. I’ve listened to it and not much new was added. They will be having meetings with the FDA to determine where they will be going next. The company basically thought the meetings with the FDA previously went well and they thought highly of this drug and the data and felt they were encouraged by the FDA to go ahead and make the submission. They also used outside consultants who agreed that they should go ahead with a filing.

They only have about a years worth cash on hand and so it will be interesting to see what happens in the next twelve months.. Only three questions were asked and it was a very short call.

Here is the company’s press release.

Other Resuorces

Xcytrin - Yahoo! Search Results
Xcytrin - Google Search
Google Blog Search: Xcytrin
IceRocket Blog Search: Xcytrin

Technorati Tags: Pharmacyclics, motexafin gadolinium, Xcytrin

Cooked Chicken Breasts Join Tainted-Food Recalls - Forbes.com

The article has the particulars but it involves Oscar Meyer/Louis Rich chicken breast with rib meat, which is fully cooker and ready to eat. The problem is bacterial contamination, Listeria monocytogenes, which can cause listeriosis, a rare but serious infection.

As the article points out this is the fourth problem within a week. The others were fresh cantaloups, organic baby food and the peanut butter.

Some jars of Earth’s Best Organic 2 Apple Peach Barley Wholesome Breakfast baby food were recalled because they may be contaminated with Clostridium botulinum,, which can cause a life-threatening illness.

FDA Warns Consumers Not to Use Certain Jars of Earth’s Best: “Organic 2 Apple Peach Barley Wholesome Breakfast Baby Food”

The FDA has a web page devoted to the other major food safety problem last week related to Peter Pan brand peanut butter. This has involved more than 290 people in 39 states. At least 46 people were hospitalized. Seems the peanut butter from both Peter Pan brand and Great Value are contaminated with salmonella.

Update on Salmonella Outbreak and Peter Pan Peanut Butter

The cantaloupe info was harder to find but it is also on the FDA website.

Recall of Cantaloupes Due to Potential Health Concerns (FDA web page)

For cat owners the FDA has also warned consumers not to use certain cat foods due to possible salmonella contamination.

FDA Warns Consumers Not to Use Wild Kitty Cat Food Due to Salmonella Contamination

Other Sources

South Carolina Firm Recalls Chicken Breast Strips For Possible Listeria Contamination (USDA web page)

FDA Recalls, Market Withdrawals and Safety Alerts
FSIS Recalls (Meat, Poultry & Egg Products)

Technorati Tags: FDA, food safety

FDA Warns of Dangers of Internet Drugs - Forbes.com:

Seems these were all purchased from commercial websites and the FDA is investigating. It will be interesting to see if and when the web site names come out. The shipments had Greek postmarks and came in clear plastic bags.

Here is the FDA news on the internet drug mixup. Here is the most interesting paragraph to me.

Although the involved consumers have named several Internet Web sites where the products were purchased, identifying the vendors is difficult because of the deceptive practices of many commercial outlets on the Internet. FDA is investigating this illicit trade and plans to release appropriate information when it is available.

If you do have any reports along this line use the FDA’s MedWatch Online Voluntary Reporting Form.
Technorati Tags: drug price, drug safety, FDA

FDA Weighs Approval of Irradiating Produce

It is a good piece and worth watching of listening to given the number of such outbreaks in the past year.

Technorati Tags: e coli, irradiation

FDA Weighs Approval of Irradiating Produce

It is a good piece and worth watching of listening to given the number of such outbreaks in the past year.

Technorati Tags: e coli, irradiation

Whistleblowers Help Congress Strengthen U.S. FDA

Along with four other current and former FDA employees they are working with Congress on improving drug safety. I think having some defined process that brings together all potential resources for drug safety definitely needs to be done. However, there needs to be more than just a collection of information and if a new branch of the FDA is created, it may not solve the problem since it would be part of the culture that has created the current circumstances. I’m more in favor of changing the culture within the FDa and get it to focus back on it;s priority of protecting consumers.

I’m all for improving drug safety but think too many times the approach is too stringent or doesn’t address the root cause. Although there have been some high profile cases such as Vioxx and Ketek recently and the FDA really hasn’t done a good job of handling the media, I think that may be changing now that they have a full time Senate confirmed commissioner. I also think too many times there is a knee jerk reaction without thinking through the ever-present “law of unintended consequences”. This is an important issue and one that

If you want to keep up on legislation in Congress regarding pharmaceuticals and the FDA, Mark over at Eye on FDA had a nice posting listing legislation before Congress. I had been meaning to put something together but he beat me to it so I’ll just refer you to his posting.

Technorati Tags: antibiotics, Congress, drug safety, FDA, Ketek, Sanofi-Aventis

FDA Approves Orlistat for Over-the-Counter Use (FDA.gov)

The following Medical News Today article has more information.

FDA Approves Over The Counter Weight Loss Pills (Medical News Today)

I have mixed feelings about this. The article makes clear that this should be used in conjunction with diet and exercise but I think too many people may view it as an easy way to loss weight without any effort on their part. I think it appears to be useful for people in conjunction with diet and exercise and I am all for helping people become healthier. Bit it also seems to play into the American obsession with losing weight without putting forth any effort on their own part. It will be very interesting to see how Roche (the makers of Alli) what kind of advertising they use to promote this drug.

This is the first time the FDA has approved an over-the-conter weight loss drug.

Other Resources
Yahoo! News Search Results for xenical FDA over the counter
xenical FD over the counter - Google News

Google Blog Search: xenical FDA over the counter
IceRocket Blog Search: xenical FDA over the counter

Technorati Tags: Ali, FDA, weight loss, Xenical

Senators Ask FDA to Keep Regional Labs - washingtonpost.com:

They have written to Dr. von Eschenbach and asked that this be reviewed.

“We recognize that FDA faces serious budget constraints that force difficult choices, but it is far from clear that consolidating ORA labs is a reasonable response to these difficult constraints,” they wrote.

It will be interesting to follow up on this since the FDA had said these labs would be closed by April. That is a very short timeframe given how slow Congress usually is.

I am wondering, given the timing with the e.coli problems, if this wasn’t a gamble to increase their budget? I personally doubt it and think it is much more likely to have been a typical bureaucratic response to dealing with an insufficient budget.

Technorati Tags: FDA labs

Online NewsHour: Newsmaker Interview | FDA Overhauls Drug Oversight | January 31, 2007 | PBS:

Several interesting thing I picked out were as follows:

• All the initiatives announced earlier this week will be done within their current budget.
• The pilot program for “report cards” will start in March 2007.
• Reiterated this is a first step in an ongoing processes.

I found this exchange interesting. Margret Warner was trying to get at how the FDA will handle situations where there is disagrement between scientists such as the recent Vioxx case.

MARGARET WARNER: Well, let me ask about a specific examine, because when Congress looked into the Vioxx situation, there was testimony on the Hill that there had been scientists who had expressed misgivings about Vioxx’s safety, and they had been basically overruled or were not listened to by FDA managers. Is that going to be corrected?

DR. ANDREW VON ESCHENBACH: Yes. Well, in the sense that we have to have processes in place where differences of opinion can come forward when there are needs for that to come through, an ombudsman function or be brought for resolution, those processes have to be in place.

The interesting thing is, although he did answer the question (but it was a simple yes or no question) he didn’t have any specfics. In other cases, he had specifics but in this case it was just, we need to have a process.

Overall, I thought it was a good interview and hopefully these initiatives will indeed be the first steps in improving the FDA and drug safety.

Technorati Tags: FDA

FDA Reinforces Commitment to Drug Safety (from FDA website; just a press release)
The Future of Drug Safety — Promoting and Protecting the Health of the Public (actual report)

This report outlines the FDA’s response to the Institute of Medicine Report a few months ago and include making “report cards” on unusual side effects. Mark over at Eye on FDA has a great post about this.

This has brought up concerns about patients seeing these “report cards” and stopping taking their medications. I agree this is likely and think it has more to do with helping the general public understand risk and probability. We humans seem to have difficulty with understanding probabilities. I have taught classes on statistics and probability and know that it is difficult to help people gain an understanding.

I think the FDA is trying to head off the changes Congress is likely to make in the Kennedy-Enzi bill (not yet introduced), but that it is likely too little too late to avoid sweeping changes coming from Congress. While I applaud the initiative, I think it is being done with limited enthusiasm and later than many would like. Also, I do think that any Democratic back billed giving increased authority to the FDA will likely lead to a presidential veto if it gets through both houses of Congress.

Until the FDA has the ability to fine drug companies for not following through on their promises of post-marketing studies, I don’t think much will change. They need an ability similar to the EPA to allow the FDA to fine companies for not complying. Right now, the only alternative the FDA has is to remove a product from the market, something I think everyone agree should be a last resort. And it should be meaningful amounts that really make the drug company want to avoid fines. I would purpose that the drug company be fined the equivalent of whatever they earn on a daily basis. As an example, if a drug earns $1 billion in revenue annually, then the fine would be $2.8 million per day for every day late they are in starting a required study. Obviously there should be the ability for the company to present to the FDA why they can’t start a study and if the FDA concurs, then a new date would be set. Otherwise, the FDA starts the fines.

The other obvious need is for more money to be able to adequately do their job. If you look at the amount of the gross domestic product the FDA overseas, and then look at their percentage of the overall budget, it is vastly out of whack.

Here are some other articles on this news.

FDA proposes drug safety “report cards” (from BusinessWeek)
FDA to Monitor Post-Market Drug Safety (from HealthCentral)
PharmaLive: FDA Reinforces Commitment to Drug Safety

Other Resources

Yahoo! News Search Results for FDA drug safety
FDA drug safety - Google News

Other Blog Posting

Google Blog Search: FDA drug safety
FDA: See what people are saying right now on Technorati

Technorati Tags: drug safety, FDA