From the lectures this week, we learned how many of the documents put forward by medical device companies to the FDA are propriety information and although the synopses can be found, the full documents need to be kept a secret. To me, this makes sense, because you would not want someone taking your information and adding it to their product and releasing it before you were able to put your product to market. In terms of clinical trials, in vitro, and in vivo studies, how much do you think should be made available to the public? Today, many people do not listen to the news or other officials because they feel most stories are told with a bias one way or another.
Do you think that the data should all be put out to the public about the success or failures of new devices, biologics, or drugs, or do you think most of this should be kept internal with synopses released to the public, or somewhere in between? How much transparency do you think the FDA should require from different companies in industry or academic labs researching medical device products, drugs, and biologics? Do you also think that transparency would help people dissociate science and health matters from politics?
I like this question as it asks us to regulate the regulators. In this charged media atmosphere with misinformation running rampant; important data about regulated items that may affect the health of consumers should be easy to access. Preliminary clinical data should be handled with more caution, as it already is. Pre market submittals often contain proprietary information, and the FDA should be trusted to handle that information carefully. The applicants themselves should be as transparent as possible with the FDA as to ensure the safety and efficacy of their products. If they should somehow circumvent FDA guidelines, the health of many could be put at risk. Transparency at most levels would help build trust in an important agency, and keep consumers well informed about products that can affect their health.
This is actually a very interesting topic. For the data, I definitely believe that the public should be given some idea of the medical devices, drugs or biologics that are trying to be released into the market. Yet, I believe that all the data should not really be released to the public since not everyone would completely understand the data unless they have some type of science- based degree. The public doesn't really need to know every little detail unless someone was trying to create a similar product that will be using some features from other possible ideas.
When it comes to the FDA requiring transparency from companies in both the industry and academics, I think that they should require 100% transparency. The more transparent you are with your data and product, they more the FDA has to work with to determine whether it would be safe for the public. With being more transparent, you won't put yourself at risk for going to jail if your product potentially harms a person that had used your product.
With how media is nowadays, even with the given science, some people will just refuse to believe that data in front of them. I believe that even if you are transparent with people about the all these medical products, someone would find a way to twist the data to fit their own beliefs and political stances. I definitely think transparency is very important but most of the data that the public would been receiving might have to be formatted in a way that is easier for someone that has no knowledge of science to understand.
I like this topic because it mentions the relationship between the government department, companies, and the public. Although the transparent data might result in imitation from other companies, I think the product's data should be open to the FDA. Moreover, reproducing experiments from other companies or labs might find problems before markets. However, I don't think the data should be transparent to the public. People who want to access the data should have permits or expertise in this field. The misunderstanding of information spreading from the media would result in public suspicion, which would make the FDA send the document to go examined again. Going over the process again would delay the market time of the product, and it even affects the duration of the patent sometimes. I agree with knm7 that transparent data to the public should be transformed into an easier way to understand or authorization by some professional organizations.
I think the FDA should require more transparency from companies about their products before approving them, because they will be utilized by the public. Especially for new drugs and medical devices, I think it is important for companies to be transparent about the expected results for the drug as well as the potential risk that could be associated with it. Of course, like how other's have mentioned, having information and data on the product be more transparent to the FDA will also make it harder to approve, which is likely why companies would be hesitant in providing all the information pertaining their product. However, companies need to understand that their products will impact people's lives so it important that any data is released so that any potential risks can be determined and released.
Transparency allows for trust, so there is potential for people to be more willing to trust the medical treatment and prescriptions they are given for their ailments. However, I do not think that everyone will be trusting of these products. Politics will always have an influence on healthcare whether it be for budgeting reasons, ethical concerns, or just general beliefs. Certain politicians could be against a drug due to the nature in which it was made going against their beliefs, which could influence their supporters to form mistrust towards said treatment, despite what scientific evidence there may be.
This is a really interesting topic because no one ever really knows how much information is sufficient. Similar to the previous replies, I also think that companies should be 100% transparent with the FDA regarding information (good and bad) on their product. To begin with, as we've learned, the FDA is in charge of regulating medical devices, drugs, etc. to ensure that marketed products are both effective and safe for public use. If companies can demonstrate safety and efficiency of their products by presenting information on the data collected from pre-clinical and clinical trials, as well as details on how their products were developed, then we have a win-win situation. To explain, more information proving the safety and efficiency of products likely speeds up the process of FDA approval (company wins), and ultimately the FDA prevents harm to the public (FDA and public wins). @hmara made a good point above that the FDA should be trusted to deal with all of the information provided carefully as some information is confidential. Therefore, I don’t think that every detail of how the product was developed should be exposed to the public since other companies may want to copy those methods. However, data from clinical trials, in vivo, and in vitro studies should be provided to the public. Some of the previous replies mentioned putting forth this data in a simplified way so that everyone can understand (even those who are not in the STEM field), and I definitely agree, but it’s important to provide all of the details of these scientific studies for those who are in the field as well. In industry, deadlines are very important, so researchers need to avoid “reinventing the wheel” and use data that has been previously published. In addition, published in vivo studies are useful since these procedures are not always feasible and can be invasive. Therefore, if the details and data collected during the research phase of medical device development are published, then other companies will avoid invasive in vivo procedures and save time/resources during their device development process.
believe that all the data should not really be released to the public since not everyone would completely understand the data unless they have some type of science- based degree. The public doesn't really need to know every little detail unless someone was trying to create a similar product that will be using some features from other possible ideas.
I go against this statement as we, coming from engineering backgrounds, the hard work and the dedication there is behind a product or an experiment. Revealing all information can be very dehumanizing to the efforts that went into making the product. I agree with releasing a common description but I don't think that trade secrets and other IPs should be revealed.
On the same hand, REading about posts where there are mentions about companies being transparent with the FDA is something I agree with. FDA is the only organization that is between me from trying a new pill, recovering my health, or getting 'antifreeze elixirs in my body.
Transparency between the company and FDA - Yes
Transparency between the company/FDA and Population - No
This is a really interesting topic not only because both sides have valid arguments, but also because it is so vital to the overall impact of the studies for each device. As the lectures on regulatory focused on the documentation and validity of the studies, it is clear that the FDA has strict guidelines that they expect ample information and research to come with each device application. I think it is more important for the public to understand what exactly these guidelines pertain to, rather than the exact data from the studies. Someone above mentioned that the public would need some sort of science degree to understand this data, I do not completely agree with the statement but there is possibilities that the research can be too complicated for some to comprehend the end results. I think that this brings about a possibility for the FDA to look into requiring "customer facing" or "end user facing" documents that would explain the overall results to the public for both new and existing devices. This way, the company can protect its confidential data from studies, the FDA and regulatory can ensure that all the data and statements are accurate, and the public or consumers can get an understanding of the results and the risk associated as well. I'm curious to see what others feel about this compromise type of approach to this question/situation!
It makes sense to not reveal too much about a device to ensure that other competitors cant copy the mechanics of it. Concerning the data about fail and success rates in trials, I don’t believe that it needs to be broadcasted to the public but I do believe that it needs to be publicly accessible. There needs to be transparency about the devices that are being placed into the body of others. It may not always be the best to directly state all the facts to the public, especially when a large amount of the public may not fully understand what is being stated. But having the information out and readily available for those who do want to know more seems the better option.
I agree with most of the commentors here saying that a company needs to be 100% transparent with the FDA. It's for the safety and efficacy of the device coming to the market and it is 100% necessary to avoid problems with the device before they start. I would rather get a notice to rework the device from the FDA than spend time in jail for device failures due to incomplete reporting. Being 100% transparent with the FDA on any given device is in the best interest of everybody. The real question lies with how much information is available to the public. I'm actually of the opinion that more information should be available as opposed to less. I am less knowledgeable in the subject, but I believe the originality of a device can be protected through patents. Perhaps certain information like methods of fabrication can be left out, but I think the qualities of the device itself and the design rationale could be made public. Especially in the case of a Class III device, patients can be informed of exactly what is sustaining their life and how it is achieving that function. I believe better-informed patients are the crux of better healthcare.
As mentioned by multiple people above, close to 100% transparency is required. However, I do not necessarily agree that transparency is requried in the pre-clinical phases of product development; only the trials of the released prototype should be made public. Nonetheless, post-market surveillance should not only be mandated by the FDA, but it should also be made public. The reason for this is to ensure equitable coverage of all medical devices. Otherwise, companies whose products are recalled are disproportionately spotlighted in the media, while other products from other companies may also be having adverse effects under the FDA's radar. This way, journalists can alert the public of any medical device that should be refrained from usage. Furthermore, it prevents the creation of monopolies, as every company would then have equal coverage on the FDA's website for adverse effects, meaning that if one large corporation's product was under investigation, consumers would still be able to buy generic products from other organizations
To my knowledge, general regulations and restrictions on what is the acceptable threshold or guidelines for a medical product should already be listed on the federal website. Of course, not all medical products are treated the same because of variations or purposes that they serve so there might be limited amount of changes to said guidelines. That being said, I think in terms of publishing specific data about companies products might be close or treading on revealing sensitive patented processes or technologies that these companies are trying to get approval of for the general market. I believe that collecting data on successful and failed products and prototypes can be used to improve future generation models, but it would not be necessary to publish a detailed summary every single time because in R&D there is often many experimental prototypes that have either been phased out or failed because of testing.
You have brought up some good points that transparency of data would lead to a more thorough evaluation and benefit both companies seeking FDA approval and the public but there are potential drawbacks and challenges from this approach.
The main concern is the protection of the intellectual property of the companies. Companies invest significant resources in research and development, and disclosing all this data may lead to competitors replicating their work without permission, potentially undermining innovation. An argument of balancing the transparency would come up but are you really being transparent if just the summaries of the clinical trials are released? Where would the public validation of the trial come from?
Also, companies that choose to share more data might feel at a competitive disadvantage if their competitors do not follow the same level of transparency. Then, there is another step of complex legal and regulator requirements that the company must adhere to when sharing this data.
Overall, companies need to be transparent with their data without potential drawbacks in the long or short term. It requires careful consideration of the specific circumstances, the nature of the data, and the overall goals of public health and innovation
Hello,
The question of transparency in the medical device, drug, and biologics industry is multifaceted. On one hand, transparency is essential to ensure public trust in the safety and efficacy of these products. It allows patients and healthcare professionals to make informed decisions about their use. Moreover, transparency can help hold companies and researchers accountable for the outcomes of clinical trials and studies, which is crucial in maintaining the integrity of the regulatory process. However, as you mentioned, there are concerns about proprietary information, potential biases in reporting, and the need to protect intellectual property. Finding the right balance is key. While complete transparency might not be feasible or desirable, there should be a reasonable degree of openness. The FDA should require companies and academic labs to disclose detailed synopses of their research findings, including both successes and failures. This information should be made publicly accessible to allow for independent scrutiny, peer review, and the ability to spot any potential issues. The full documents containing proprietary information can remain confidential, but mechanisms should be in place to ensure that the FDA and relevant regulatory bodies have access to them for thorough evaluation. Transparency can indeed help people dissociate science and health matters from politics by providing a foundation of evidence-based decision-making. It reduces the risk of public perception being influenced solely by political narratives and fosters trust in the regulatory process.
