2007 – New FDA oversight to take place – Democrats Rule – Now What?

Well, it has been quite awhile since the Democrats were in this position, in control of the oversight of the USFDA. With the shift in power in the US Congress, the Democrats are back in the driver's seat as far as what the policies will be for FDA.

So, what does this mean for the industries that are regulated by the FDA – Drugs, Devices, Foods, and Nutritional Supplements (to name a few)?

One thing is for sure, there will be changes, major changes in how the FDA will oversee and regulate these industries to “protect” the American public.

If you are not quite sure of the picture that is being presented here, while the Republicans were in control of the House of Representatives, they had the oversight of the FDA and monitored their policies. The Republican Party has been over the years much more “industry friendly” and took the position of “liaise fare or buyers beware” letting the marketplace control things.

Well, the Democrats take a much different outlook on consumer protection. They believe that it is the governments place to protect the public and to make sure that “buyers beware” is something that the buyer need not be.

Which form of oversight is better? That depends on which side of the tracks you reside on. If you feel that the liaise fare policy is best and that type of government oversight provides more competition, new and improved products and lower prices with the possible effects of the consumer being compromised to some extent, than you were pretty happy with the last 12 years of Republican control in Congress. If you feel that this competition of bringing new products to market faster lead to possibly unnecessary deaths and injuries, that there was less regulatory control of companies and unregulated products on the market, then you will be very happy with the next two years with the Democrats in control.

So, what changes could we foresee will be in the next few years with the new “Guard” in control?

We think that there will changes in the following areas (at least):

1. The pre-notification of inspections for domestic medical device companies will be done away with and that companies can expect to see the FDA knocking at their doors unannounced like it was back in the “good old days”. The FDA already had reduced this pre-announcement of a pending visit for companies in compliance from 5 days to 3 and in come cases even 1 day.

a. Foreign inspections will still be pre-announced since it cost the FDA too much time and money to make a visit and learn that the company was closed.\

2. Warning letters will be issued at a much higher rate and their follow up with be more closely adhered to to determine the company’s compliance.

a. In the last few months it appeared that warning letters were being issued at a higher rate.

3. Nutritional supplements will be high on the agenda for review to determine their correct labeling and safety as well as effectiveness. These products have had a free ride over the last 12 years and it was a true case of “liaise fare”.

a. There has been too many problems with these products and it appears that there are more and more of these products on the market shelves with more and more claims that have not been substantiated.

4. Third party audits will probably be done away with, though they had not been readily used by the industry. This whole concept of having a third party audit under the FDA regulations similar to the ISO audits was never a good concept for the start. I know that the government would like to farm out all their work to decrease their expenses, but using third party audits similar to the ISO certification audits to inspect for FDA QSR/cGMP compliance when the FDA regulations are not a voluntary requirement but a legal one, is not the way to go. Consumer protection would be greatly compromised by this type policy.

5. A friendlier FDA that could be negotiated with on regulatory issues will probably be history as the FDA will take a much harder stand on bring legal actions and demanding compliance of the industries.

6. Third party 510(k) review will probably stay intact but it will be given closer scrutiny.

7. The new QSR for the pharmaceutical industry will be implemented and will be given closer monitoring during FDA audits.

You can be sure that with the change in power, there will be TWO things for sure:

1. There will be change in how the FDA will monitor the industry.

2. The industry can expect that these changes will not make things easier for them to comply.

Expect to see new policies and regulations in 2007 and extend into 2008, when the next Congressional election takes place, and by the way a new President will also be up for grabs.