There have been a number of discussions about importation of drugs from countries that negotiate lower prices with the drug companies. The FDA (or "the Agency" in industry-speak) has said that it cannot assure the safety or efficacy of imported drugs. In the extended text, I outline some of the regulatory difficulties associated with the importation issue and some initiatives that are currently underway to harmonize regulatory issues across the different markets.
I believe that progressives tend to have a knee-jerk response on issues related to drug prices. As I always say, drug companies are corporations with stockholders. They are not charities. Their primary goal is to turn a profit. This is certainly not comforting when people are not able to afford medicines they desperately need. It is just a fact. I post these diaries to provide information from the other side of the aisle and try to outline some of the complexities associated with the industry because I believe that a well informed public makes well informed decisions. So here is another dispatch from Inside the Evil Empire.
The Agency has stated that it cannot assure the safety and efficacy of imported drugs.
http://www.fda.gov/importeddrugs/
There are multiple factors contributing to this statement. I will not deny that Pharmaceutical companies are a powerful lobby and they are able to influence legislation to keep prices high. The prime example is the Medicare reform disaster that prohibits states from buying drugs in bulk. Purchasing drugs in bulk quantities significantly decreases the cost (as any patron of CostCo can tell you) and I view this as the single most important reform that can be immediately implemented. The drug importation issue is more complicated because of the regulations used to file and release drugs in the different markets. I will consider new drugs and generics seperately.
The regulatory power of the modern FDA was born with the Barr Decision. The Agency won a decision against Barr and was awarded new enforcement powers to go after companies in violation of the federal laws governing Good Manufacturing Practices (GMPs) - described in 21 CFR Parts 210 and 211 (http://www.gmp1st.com/drreg.htm ). The CEO of Barr went to prison and federal marshals put up the crime tape and locked the doors. You can read more than you ever wanted to know about the Barr Decision here:
http://www.gmp1st.com/barr1.htm
The regulations for filing new drugs in the US have evolved since Barr. For example, 21 CFR Part 11 was issued to address storage of electronic data and use of electronic signatures. The regulations change with technology and have generally expanded in terms of what the Agency requires. The process for filing a new drug is based on different development phases with specific expectations at each phase. For example, part of the drug development process is establishment of an expiry date. There are rules stipulating exactly how these studies must be performed (drugs must be stored in environmental chambers at specific temperature and humidity levels and tested using validated methods). If the Agency requirements are not followed, an application for a new drug can be rejected.
The filing regulations are different for different markets. The Europeans have different expectations regarding analytical method validation and acceptable levels of solvents. In most cases, the differences are not significant enough to cause the release of unsafe drugs, but the Agency will not allow the sale of drugs in the US that are not filed according to the GMPs. They cannot legally make a statement that the drugs are safe because they have a legal definition of safety in their own regulations. Allowing importation of drugs from other markets would call all of our own regulations into question.
There is an initiative currently underway to harmonize the regulations for the different markets called the International Conference on Harmonization. They are attempting to align some of the requirements for the different markets to make filing easier. Under the current Medicare regulations, this won't do much to bring down drug prices because you still won't be able to import. However, it will make filing in different markets much easier for the pharmaceutical companies because it will greatly reduce the amount of data needed during drug development. Eventually, I could envision the different Agencies aligning to allow importation. Here is more on ICH if you are interested:
http://www.ich.org/UrlGrpServer.jser?@_ID=276&@_TEMPLATE=254
And then there are generics. As much of a mess as the new drugs are, I wager that the generics are worse. Generally speaking all drugs are manufactured according to GMPs. The difference for generics is in the testing. Each market has it's own pharamcopoeia for generics. The pharmacopoeia describes the testing that must be performed to release the drug in that particular market. It also provides details on how equipment should be used, samples and standards should be handled and general guidance on just about every aspect of laboratory operation. A company that develops a new drug also develops all of the test methods. When a drug becomes a generic, those methods are included in the pharmacopoeia. Over time, changes can be proposed to implement new methods or eliminate methods that are not longer applicable. One way that Big Pharma occasionally "messes with" smaller generics is by developing methods using obscure technology and filing them in the pharmacopoeia. This forces generics (who normally operate on razor thin margins) to implement expensive new technology - but I digress.
The testing used in the different markets can be considerably different. Even standard tests are performed slightly differently (start with 1 g for Japan and 2 g for US). Again, I don't believe that it significantly impacts the safety or efficacy of drugs manufactured for other markets, but the Agency cannot say that the drugs are safe. In some cases, a huge lot of a drug will be broken into smaller lots and tested for release in different markets (sometimes you will see name-brand drugs and generics manufactured in the same batch, the batch is portioned before tableting or encapsulation). The industry would love to see more of the pharmacop0eial compendia harmonized because the differences make operation of Quality Control labs much, much more difficult and mistakes more common when analysts are testing the same substance three or four different ways.
And that is probably way too much information on this subject. The importation issue is very complicated from an industry perspective. Personally, I think it would be easier to allow states to negotiate for bulk purchases. We could use either the Canadian model (negotiating for a single product) or the Japanese model (negotiating for all products in a company's line). Something will have to give eventually.