All loopholes in the law related to aborted clinical trials and trials that fail to get completed need to be removed as soon as possible through legislative action. The present loopholes, which allow companies and the FDA to keep data from aborted and unfinished medical device trials in a "black box," not only endangers the American public and most specifically trial participants, but also keeps science from moving forward and undermines any appearance that the FDA is operating in a transparent manner.

I think that drug companies should be required to post all of the unfavorable clinical trial results, instead of just the favorable studies, like they've been doing. I also think that all conflicts of interest, like the APA's drug company funding, must be made totally transparent.

All clinical trial results should be disclosed to the general public for both their safety and information. While a trial may fail, that doesn't mean all physicians are aware and as an advocate for your own health, the public should have pertinent material to present their case as needed. Some trials can potentially affect a person years later. Without knowing trial results, all patients are hampered. This legislation should be put into effect immediately. Thank you.

Mrs. Maurice Hogue

Two items are very important for the public to know:

1) The results of ALL clnical trials, whether favorable or unfavorable, whether successful or unsuccessful. The public, and especially the people who have participated in these trials, have the right to know.

2) How many sucessful trials have to be performed before a drug or device is approved by the FDA? Is there any legislation regarding this? Those of us with implants inside our hearts for PFO closure (with PFOs that caused stroke, TIAs and/or heart failure) would really love to know when these devices will be approved by the FDA for PFO closure. What more criteria do they need to meet? The devices have already been approved for ASD closure, so why not for PFO closure? Perhaps legislation needs to be passed to make these devices available to the public? I am not sure how the system works, but explaining this to the general population will be a great big step toward transparency. I would be interested to know how the FDA goes about making a decision to approve a device or medication for use for specific ailments and conditions.

I agree fully with what Bray and "Duck Tape" are posting. I think that ALL clinical trials results, whether successful or unfavorable, should be made public. Not only is it appropriate, it's safer. As Americans at the VERY least, it is our RIGHT to be well informed!

With regard to processes and decision-making, the approval process for products and drugs should be made public. Not only should the studies performed on a product or drug be made public on the FDA website, but also information about where the funding for the study came from.

While I applaud the FDA’s efforts to make procedures and processes more transparent, I believe transparency is a much smaller part of a larger issue. A window is transparent. But, what good is a window if you do not believe what you are seeing through that window is what is actually there? There needs to be a restoration of trust among the public with regard to the FDA. You can be as transparent as you want, but if the public does not believe that the information provided is truthful, it is useless. Public distrust of the FDA greatly impedes the impact an approval or warning has on the population.

A process that would increase both transparency and trust would be the development of, as an example, a 0-5 star-based grading system. The individuals who grade products and drugs should be employed part-time by the FDA and not located at the FDA headquarters to prevent politics and pressure from influencing decisions. The number of stars could indicate the degree of confidence a consumer can have in a product or drug with zero stars being the least confident and 5 the most. This system could be applied to nearly everything the FDA approves.

For drugs: New drugs would have 0-1 stars unless studies had been conducted by independent agencies indicating safety and efficacy. The longer the drug is on the market without severe adverse events and/or the more studies conducted, the greater the number of stars would be assigned to the product.

For supplements: I realize the FDA does not regulate supplements, but this process would allow for increased consumer confidence and safety. If the manufacturer is willing to pay for testing, products that contain what is listed on the label without added dangerous ingredients (lead) would receive a high number of stars and those that do not contain what is on the label and/or contain dangerous ingredients would receive a low number or no stars. Advertising the system would encourage those that was to increase consumer confidence in the safety of their supplements would likely pay for testing.

GRAS List: Similar to medications, items on the GRAS list can receive stars based on the number of studies and the results of those studies.

This system could be applied to products, cosmetics, foods, and all items that are FDA approved.

This process would make it easy and convenient for consumers to purchase products with some knowledge regarding the potential risks involved.

Consumers assume that just because they can buy it at stores that it was "approved" by the government. They automatically think that if they are able to buy it in a store that its safe. The FDA needs to let consumers know that not all products have been approved by the government.

Soon after my daughter was diagnosed with a life-threatening food allergy to sesame, I wrote to FDA and asked if FDA was considering regulating sesame along with the other allergens already covered under the FALCPA.

On March 10, 2008, an FDA employee from the Center for Food Safety and Applied Nutrition replied that:

“We have to assure compliance with the current regulations but I have no idea what the future may hold. If/when a change is implemented it will be announced. We are not permitted by law to discuss any issue before us for consideration.”

If indeed there is a law that prohibits FDA from discussing with the public whether they are considering regulations in a specific area, this does appear to be a major obstacle to FDA’s desire for transparency and increased communication with the public. I would suggest that this law should be changed.

On the other hand, if there is no such law, this would argue for the need for questions from the public to the FDA to be posted on a public site like this so that consumers can get accurate answers and hold FDA accountable.

I did save this email correspondence.