AIDS TREATMENT NEWS Issue #306, November 6, 1998
Tadd Tobias and John S. James

* Generic testosterone cypionate has been unavailable for weeks in San Francisco, and presumably throughout the U.S. (although some stocks may still remain). No one is currently manufacturing generic testosterone cypionate or enanthate for the U.S. market, and there are no immediate plans to resume production.

* Testosterone enanthate, according to two leading HIV physicians we contacted, is basically equivalent to testosterone cypionate and can be substituted for most patients (rarely someone may be allergic to one but not the other). Generic testosterone enanthate is currently in stock in many pharmacies, but shortages are expected. One San Francisco physician has had no problems prescribing it, with patients filling their prescriptions at pharmacies. But another physician, whose managed-care contract requires that he inject the drug in his office, has been unable to obtain supplies even after calling distributors around the country; he has also had problems obtaining nandrolone decanoate, an anabolic steroid.

* If the generic drugs are unavailable, physicians can use brand-name versions, which cost several times as much--or switch to other expensive options such as one of the testosterone patches, (Androderm« or Testoderm«) or the oral anabolic oxandrolone (Oxandrin«). At least one non-generic testosterone product--Depo-Testosterone« 200mg/10mL--has been back-ordered since September 28. A brand of testosterone enanthate--Delatestryl«--is available, with no supply problems expected. The same is also true for the testosterone patches whose manufacturers have told AIDS TREATMENT NEWS that ample supply is available.

* The additional expense is especially problematic for HIV physicians under certain managed-care contracts. Even in San Francisco, some leading HIV specialists have been forced into contracts with no AIDS "carve out"--which means they are paid about $5 per month to cover office visits for a person with AIDS, the same as for a healthy middle-aged adult. The additional reimbursement for a testosterone injection barely covers the cost of the medicine for the cheapest generics. Many physicians who specialize in AIDS care are losing money on every patient and being forced to pay for their AIDS practice by taking on other work; they have no margin to cover the sharply increased cost of non-generic testosterone.

How the Shortage Happened

On September 10, 1998 the FDA moved against Steris Laboratories, Inc. (a division of Schein Pharmaceutical, Inc.), seizing large stocks of their drugs and ordering a halt in further production of all products at that facility; Steris, located in Phoenix, Arizona, laid off about 350 workers. The FDA has not said that any of the drugs are bad, but that the company had not followed required procedures for documenting quality assurance.

Steris had been manufacturing all the generic testosterone cypionate and enanthate sold in the U.S., even that which is sold by other companies.

On October 16, 1998, a "Consent Decree of Condemnation and Permanent Injunction" between the FDA and Steris allowed the company to resume distribution of some but not all of its products. The consent decree (which is public information) includes an "Exhibit C" of drugs which the FDA has determined are medically necessary. Steris will re-test the seized stocks of these drugs, and return them to the market if possible; also, it will resume manufacturing, when permitted, for these products. However, Exhibit C does not include any form of testosterone, apparently because the FDA believed that enough other companies were marketing equivalents of the drug; the FDA has approved about three dozen testosterone preparations of about a dozen different companies, but at this time does not know how many are currently on the market. Exhibit C also includes chorionic gonadotropin 5,000 U/vial and 10,000 U/vial (sometimes used to help restart endogenous testosterone production after discontinuation of testosterone therapy) and nandrolone decanoate 100 mg/mL and 200 mg/mL-- suggesting that if any shortages of these drugs develop, they should be temporary.

Steris did list testosterone cypionate and enanthate 200mg/mL in Exhibit A (drugs it wants to resume manufacturing when possible). It lists a lower concentration of both testosterone cypionate and enanthate (100mg/mL)--and also nandrolone decanoate 50mg/mL--in Exhibit B (products it may withdraw from the market).

Call for Information

We have been told that no generic testosterone cypionate or enanthate is currently being manufactured for U.S. sale. Pharmacies and distributors may have inventory of enanthate, and manufacturing may be resumed. Most of the non-generics should remain available. If you have any additional information about supply of generic testosterone, non-generic testosterone, nandrolone, other anabolics, or chorionic gonadotropin, please let us know; contact Tadd Tobias at AIDS Treatment News, 415-255-0836 or ttobias@aidsnews.org.

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