Today, the only thing the consumer can trust is that the manufacturing process and the plant is being inspected by the FDA and so they assume that the product is safe. We now know that all the foreign plants do not get inspected by the FDA and even if the Congress provides more funding to the FDA, it is going to take years and a lot of the tax payers’ money to fund the FDA adequately so that they will have enough inspectors to inspect thoroughly all the foreign plants as they do for plants in the US or Europe. Why should the U.S. tax payer subsdise the drug companies so that they can get their products made abroad cheaper while making it unsafe for our consumers? The Congress should pass a law that until and unless the FDA is able to inspect thoroughly a foreign plant and provide a rating for its manufacturing quality, drugs or drug components made in that plant should not be allowed to be sold in the U.S. In addition, a drug company who wants products to be imported from abroad should pay for the cost of inspecting that plant and ensure that products made in that plant are safe. That way, the tax payers do not have to fund the inspection process. In the U.S. if a drug company submits an application for approval of a new drug, the company is not allowed to market the drug in the U.S. until the FDA does a complete inspection of their manufacturing facilities. Why should there be a different standard for foreign manufacturers? We are using tax payer dollars to inspect these foreign plants which could be used at home to invest in research in product development and manufacturing science to make our products cheaper and safer. That is a much better way to spend our tax dollars.

In this case, the wall sconces seemed like the perfect solution b/c the bathroom lights are on the backside of the wall where the sconces are and the bathroom wall was damaged and needed repair, so putting a few more holes in it before patching things up made sense. I wasn’t sure about permits and codes, so I asked several different people who to contact. All of them gave me the same name. We have this woman named Marge who works in city planning and zoning. Marge makes sure that inspections and enforcement are carried out. If you have a question, you call Marge. She is polite but firm and knows how to get things done. If Marge has a question or concern, Marge calls you and lets you know. If you are smart, you’ll listen to what Marge says because even if you don’t like what she has to say, you know that she is just doing her job.

After reading the recent GAO report on FDA foreign inspection deficits and the Harris essay, It is ironic that Marge’s oversight and enforcement of the permiting and inspection process for my new wall sconces appears to be more rigorous and better organized than FDA’s licensing and inspection of foreign plants. I wish that I could vote to allow Marge to clean house at our state pharmacy board.

Although we’ve lost a large number of them, there are plenty of FDA career employees left who are like Marge…they take pride in their work and in keeping patients safe. I just wish that like Marge, they could pick up the phone and tell Gardner Harris, FDA legal, and certain members of congress what they think we should be doing in the face of outsourcing and globalization, and what they need from us to help them do their job of ensuring and enforcing USFDA standards in foreign countries.

In the branded pharma industry serious manufacturing problems have been rare in the last 30 years. When you make $5 per pill it pays to spend the extra ten cents to avoid shutdowns due to inspection issues. In the generics industry manufacturing problems have tended to be more serious due to the extremely narrow margin. However, the recent price pressure has led to branded companies outsourcing much more extensively with large pressure to cut costs.

Sure, if pre-emption doesn’t become the law of the land you’ll have the comfort of being able to sue some major institution out of existance when they kill thousands of people with a tainted drug (fifteen years after the fact most likely by the time appeals run out). Granted, all the folks who profited from the scandal would have cashed out decades before and the people most impacted would be employees working on new drugs who probably were in college when the event happened. One less drug company will just reduce the rate that new medicines are discovered and make drugs more expensive (fewer companies = more negotiating power). With companies being as short-sighted as they are I doubt that the threat of lawsuits is going to make them less likely to release tainted drugs.

Wouldn’t it make more sense to issue licenses to facilities that manufacture sensitive products like food and drugs and require frequent re-inspection to maintain the license? License fees could easily pay for the cost of the necessary inspectors. An inspector would have the power to shut down a plant or bar imports immediately if necessary - rather than waiting until thousands of people have been poisoned and for the courts to sort everything out.

I wish that I could agree that when the FDA finds a problem with a US plant, the field officers recomendations are given weight and/or implemented quickly. Under this administration, legal has more oversight so things can take longer to respond to. Perhaps it would be better to say that corrections may be implemented more quickly.

Hope that you enjoy your Sunday.

Anne

I can see non-Mandarin-speaking FDA staff stumbling around China now, not even able to find the factory they are supposed to inspect. But phrma is not worried, because if the Court rules their way tomorrow, the line item for killed/pay money out will be small.