What do you think of the new Trump's 2018 budget proposal of $2 billion increase in FDA User Fees for medical device registrants for 2018? Will this have an impact on the use of de novo 510k Process? Please share your comments/concerns?
Yes, if this goes through Congress the increase in medical device user fees would affect small/midsize companies. However as the FierceHealthcare article mentions, it is unlikely that it will go through.
This article states "The fees are part of an $1.3 billion increase to all user fees that would replace the need for a new budget authority each year and “reduce the burden on American taxpayers.”"
I would like to think its nice of Trump to be considered about American taxpayers, but clearly this would be detriment to the American taxpayers in a time where such innovation is growing the medical/tech device space and solutions needed for American patients.
The user fees increase could be a benefit for the industry as it has the potential to increase the regulatory timeline for FDA. This can allow for drugs and medical devices to reach market quicker and aide thousands of patients in a more effective manner. There are also potential setbacks that can result from this move, as the increase in user fees still does guarantee a quicker regulatory timeline, the two are not necessarily correlated, in the sense that just because the FDA now has a larger war chest does not mean the regulatory timeline will suddenly increase, if the process flow is not improved and funds are not appropriated in the correct areas. Moreover, there can be a setback to the consumers as well, because these costs of increased user fees may get past down to the consumer eventually in the final product cost. So as to alexandrabuga's point above I would agree that although the tax burden may be reduced the cost will eventually find it's way towards the consumer. It should also be taken into account that this additional cost may be worth it if it is able to provide life saving devices and drugs to market with increased quality and efficiency, providing a better outcome for the patient.
Trump’s new budget proposal of a 2-billion-dollar increase in the FDA User fees has its merits but can also be a drawback. One of the biggest merits of this change would be the increased benefits for the taxpayers. However, as is the case for most of Trump’s proposed legislation, there are no clear guidelines as to how this will work. Most of his plan is not made public and the bolts and nuts of this plan are not known. Despite this fact, if Trump can pass this budget proposal it would come as a relief for many. The downside to this bill is the burden that will be placed on the small businesses. Some businesses may not be able to pay these fee increases and could result in them being taken over by larger companies. This creates an adverse monopolizing affect. Some companies may even increase the prices of their devices to compensate for the fees.
Cheaper medical device registrant fees are effectively subsidies to the medical device industry. The utility of such subsidies seems significantly higher than a federal budget cut of 0.06%. The nature of this cost increase, as the article points out, is more damaging to smaller companies. But innovative solutions in the Biomedical Engineering industry often come from such companies, which means saddling with an increased financial burden may impact or even prevent the development of novel technologies with great medical potential. These companies already often struggle to challenge larger mega corporations, which have connections and experience that make it easier to navigate FDA rules.
There are many subsidies that are less useful to all of Americans in the budget, such as the almost $24 billion corn subsidy this year. I would hope that the Trump Administration would target those, or other sources of overblown government spending, before increasing regulatory burden on the medical device development industry.
The net effect of the increased user fees seems to be pointing to increased cost for small to mid-sized businesses in the medical device field and a greater burden on the end user of the device.
Small companies that produce potentially life-saving innovations already get bullied out of the marketplace due to a lack of the vast resources that larger corporations have. By increasing the burden on these businesses, the pace of development, especially through these avenues, would be hampered. Furthermore, the remodeling would not entirely remove the burden from American taxpayers but rather would funnel the burden into the industry itself, ultimately trickling down to those who need the devices. It would not be uncommon to see the increased costs be passed to only the American taxpayers that require treatment, and this would be a much greater burden because fewer individuals would be there to bear it.
There are benefits to this proposal, as have been outlined by my peers, but it is difficult to assess it as having more pros than cons when considering the needs of the patients and of the smaller businesses in the industry.
although the FDA will potentially have more money in the long run, the delay in negotiation for a new deal will cause "substantial layoffs at the [FDA]” as the article Alexandra posted stated. this will definitely slow down review time for devices. I also agree with akashranpura that there will be a monopolizing effect. However if the smaller companies just get bought the products they're creating still have a chance to make it to market. However, as DH239 stated, many companies may also go under, which ultimately hinders innovation in the medical device industry. this proposed fee increase seems to have a negative impact on everyone.
I agree with Ibraheem Shaikh. Many affordable medicine or medical devices are developed by new firms that are also smaller in terms of financial resources. When every aspect of innovation and translation to a product is a big hurdle, this revised fee may detrimental to such companies.Even though such bills go through several revisions before congress passes it, big companies will certainly have an active role in such activities (lobbying). Furthermore, even if taxpayer’s money is saved, probably the price for new products or devices are going to be much more expensive which can be counter productive.
Trump is one of the wealthiest individual in the US; i.e., besides being elected to the highest executive office in the country. Actually, his only reason for seeking access to this thrown is to solidify the security of the wealthy. What FDA handles can very easily impact the security of the wealthy. And you ask for my concerns? It will, therefore, be unnatural to expect he will do something that not benefit the rich.
Trump's new budget proposal, which calls for a two-billion-dollar raise in FDA user fees, has certain positives, but it also has some disadvantages. The enhanced benefits for taxpayers would be one of the most significant advantages of this shift. There are no clear instructions as to how this will function, as there are for much of Trump's proposed laws. The majority of his proposal has not been made public, and the nuts and bolts of it remain unknown. Despite this, many people will be relieved if Trump can enact this budget proposal. The bill's disadvantage is the additional cost it will impose on small enterprises. Some firms may not be able to afford these fee increases, which could lead to their closure.
