The Energy and Commerce Committee's Subcommittee on Health has published the full video and written testimony from their special hearing, "Exploring Drug Shortages." It's a lot to get through - 2 1/2 hours of video testimony from a panel of eight experts including representatives from ASCO, cancer treatment centers, pharma manufacturers and regulatory agencies. But I slogged through all the written testimony and about half of the video to confirm the written testimony to sum up some key points, as did Kate Murphy for yesterday's Fight CRC Research & Treatment blog.
I know it's popular to blame the drug shortages of drugs like 5FU, Leucovorin and Irinotecan on pharma greed, saying that they'll never go out of their way to produce such low-cost/low-profit drugs. But revealed in the testimony are some surprises (at least to me) about why 54% of these drugs went into shortages. Many are made by only one company, so there's no backup if that company can't meet demand...and the biggest barrier to maintaining production (54%) is maintaining purity standards on drugs manufactured on increasingly older equipment and in older manufacturing plants. Other producers would have to make substantial investments in their infrastructure and plants, re-tooling to take on manufacturing shortage drugs. They'd also have to pass quality control standards as a new manufacturer.
When asked why supply and demand wouldn't just solve the issue, one of the expert witnesses (Dr. Koh) pointed out that most of these drugs are sold on contracts - and the manufacturers agree to provide them at X price. If they have a manufacturing problem, they have to eat any costs to bring the drugs in at the contracted prices - which come from (guess where? yep...the insurers and large-quantity purchasers.) Any new manufacturer coming to market with a shortage drug has to be able to produce it for what are often, in the light of the infrastructure of most plants, artificially low price ceilings.
It was a long read, but very interesting and much more revealing than you'd guess from the rhetoric and sound bytes about the drug shortage issue. Having worked for an older pharma manufacturing site (yep, the folks who patented penicillin), I know just how difficult it can be to maintain purity in a production line on old equipment. Manufacturing delays don't even begin to describe the problems.