Shortage of doxycycline capsules and tablets
Senator Charles E. Schumer made an appearance before his constituents in the lower Hudson River valley on Tuesday, August 12th, calling for the FDA to investigate the high price of doxycycline in the midst of a very active Lyme disease season. Yet the FDA is forbidden by law from considering price when dealing with drug shortages, and only takes into account “market coverage.”
The market is considered covered when supply is available from at least one manufacturer to cover total market demand.
Therefore you will not find doxycycline listed among the drug shortages on the FDA’s website as of this writing. The Journal News reports on its website that:
Pharmacists in the Lower Hudson Valley confirm the drug’s cost is soaring, but report they have plenty of the medication, doxycycline, on hand.
The senator is also quoted, “I don’t like the way the FDA handles drug shortages,” said Schumer. “They wait too long.” (See also the senator’s 8/12 press release.) This ignores the fact that, back in 2011, he was part of the process leading to the law by which the FDA defines and deals with drug shortages, and when manufacturers are required to report the possibility or existence of a shortage.
On the other hand, The American Society of Health-System Pharmacists reported a shortage of doxycycline on August 8th. They have a different definition of a shortage than that written by Congress, implemented by regulations, and administered by the FDA. There are specific rules, of course, but basically when hospital pharmacists report they can’t buy the drug to fill the needs of the patients in their system is when a shortage is declared.
An adequate supply of doxycycline is really important for Lyme disease, because early treatment equals effective treatment. If you see the characteristic bullseye rash, get yourself or whatever person to the doctor for treatment and you will avoid much misery later. Unfortunately, only about 70–80% of the people bitten by deer ticks carrying the disease show this distinctive symptom. When untreated, Lyme disease becomes a serious, chronic disease that is difficult to treat.
As for price, about half of all generic drugs are increasing in price, and the other half are decreasing, as per this chart from Pembroke Consulting and Drug Channels. Adam J. Fein PhD, Drug Channels CEO and Pembroke Consulting President, wrote in his blog post last Tuesday:
Surprise! Retail generic drugs are no longer getting cheaper over time.
Our latest exclusive analysis (below) finds that half of all retail generic drugs became more expensive over the past 12 months. And some of those drugs got much, much more expensive. One out of 11 generic drugs more than doubled in cost, with some increases exceeding 1,000 percent.
Product shortages appear to be the primary culprit. How did our retail drug supply chain become so fragile?
The answer in this case is demand. The 13 US states in which most cases occur are currently at peak incidence of the disease. Each infected adult routinely requires 200 mg doxycycline on day 1 and 100 mg daily for up to four weeks. Another antibiotic may be given in a second round of treatment, or doxycycline may be given again. The drug of choice for treatment of Lyme disease is doxycycline.