“Don’t Touch My Bags If You Please, Mr. Customs Man”

10/5/09

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it is supposed to contain? What’s the reputation of the seller, and how easy would that be to determine in a country where you don’t speak or read the language? Let’s assume for the sake of argument that the vial really contains the drug it’s supposed to contain. Is the packaging truly sterile, so you won’t get an infection? Is the potency equivalent to the drug available in the U.S.? It’s unlikely that a copycat drug you are buying in India or China will have gone through clinical trials that are as rigorously monitored as in the U.S., and maybe there were no trials done at all. So how confident will you be that the drug will work? How will the dosage be calculated? Finally, what assurances do you have that the drug isn’t counterfeit? Caveat emptor—there will be no guarantees that the material you are buying will be biologically equivalent to the drug you couldn’t afford back home.

Intellectual Property—This is an issue that I imagine most patients are unaware of and, even if informed, would probably ignore. As pointed out by Ellen Ruppel Shell in her well-researched book Cheap: The High Cost of Discount Culture, there is often a significant price to be paid by buying a cheaper product that is not readily apparent to the consumer. Drugs made in countries that have not honored intellectual property laws (or where IP enforcement is difficult) can be significantly cheaper for many reasons, including the fact that the companies that make them don’t pay royalties or license fees on discoveries made and patented in other nations. Some patients will attempt to justify their purchases by claiming that U.S. drug makers are making excess profits and they are simply “sticking it to the man” by buying overseas. Others will argue that they’re just being smart consumers and buying drugs at a good price. Failure to honor intellectual property laws is not an issue generally faced by those traveling to foreign countries for surgery.

Legality—Having your drugs administered in a foreign country shouldn’t be too problematic, but can you legally bring those prescription drugs back into the U.S? The FDA regulates this importation issue. The Food, Drug and Cosmetic Act prohibits importation of unapproved new drugs, according to the FDA website. “Unapproved new drugs are any drugs, including foreign-made versions of U.S. approved drugs, that have not received FDA approval to demonstrate they meet the federal requirements for safety and effectiveness.” Furthermore, the FDA has developed guidelines for “Coverage of personal importations.” The guidelines state that the “FDA should consider not taking enforcement actions,” in certain cases “when the intended use of the drug is unapproved and for a serious condition for which effective treatment may not be available domestically either through commercial or clinical means.” However, Indian or Chinese made copies of U.S. biologics would not be allowed since the drugs are commercially available here, albeit at much high prices. While the FDA has discretion over whether or not they will allow your drugs into the U.S. “foreign-made chemical versions of drugs available in the U.S. are not intended to be covered by the policy.”

In summary, buying biologics in other countries and bringing them back to the U,S. wedged in between your T-shirts and dirty socks is not so much “importation” as it is “smuggling.” Will Americans be willing to take this risk? Is it happening already? I have no current numbers to share, but would not be surprised to find that this type of travel, even with the risks involved, is already happening at some level. Whether a trickle becomes a flood may depend on the outcome of the current healthcare reform efforts.

[Editor's Note: Thanks to Arlo Guthrie for inspiring the title to this piece, borrowed from the lyrics of his 1969 ode to smuggling, "Comin’ Into Los Angeles."]

Stewart Lyman is Owner and Manager of Lyman BioPharma Consulting LLC in Seattle. He provides strategic advice to clients on their research programs, collaboration management issues, as well as preclinical data reviews. Follow @

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  • steve s

    I would like to hear Dr Lyman’s opinion on the future of outsourced development and manufacturing of biologics to China, Singapore, Korea and India. Big pharma is already building manufacturing and R&D in China and several Biotech companies are planning the same. Nektar has a major R&D site in India. Medicinal chemistry work at CMO, CRO and company owned facilities are largely accomplished overseas. Today, most if not all small molecule generic drugs are manufactured in China and legally imported to the US for testing, formulation, and distribution. That’s why Walmart can offer generic small molecule drugs for $4 per month. What happens 10 years from now to US based R&D and manufacturing of biologics when China and India have mature regulatory systems, huge biologic CMO capacity, and Big Biotech owned manufacturing sites? Can Amgen afford to not manufacture in China?

  • http://www.lymanbiopharma.com Stewart Lyman

    Steve, I delayed answering your question to give others a chance to chime in. The trends are clear that the production of biologics overseas is growing rapidly. There are a number of companies in countries such as India and China that are already manufacturing generic biologic versions (biosimilars) of epo, G-CSF, GM-CSF, insulin, growth hormone, and others for their own markets. At present there are strong barriers that keep these molecules from being exported to some countries, such as the US, although they are being exported to other countries around the world. There are a number of political, organizational, intellectual property, and manufacturing issues that will need to be resolved before we see large scale production of biologics made overseas with the intent of selling them in the US. One of the primary factors will be that the US FDA will need to establish inspectors in these countries to sign off on the quality of the drugs made there. There will need to be a significant effort to scale up manufacturing expertise and approved supply chains in these countries, and to get local government approval as well. We will see Big Pharma respond to the financial threat of biosimilars by making their own generics to compete against their branded biologics. This is already happening with small molecules. In addition, there will be an increased emphasis on second generation biologics to extend patent protection i.e. drug franchises, as Amgen has done with Neupogen/Neulasta and Epogen/Aranesp. I will also predict that this outsourcing trend will not be without serious challenges, as Boeing has seen with their outsourcing program of the 787 Dreamliner. Producing products locally with a skilled, highly trained and experienced workforce will always have certain advantages over outsourcing to a foreign country, especially when problems arise and when you are trying to make a product for the first time.