Eye on ID

Where, oh where, are the generic drugs?

The Infectious Diseases Society of America has adopted and popularized the mantra of “Bad Bugs, No Drugs” for good reasons. However, there is another very significant problem occurring of shortages of old generic drugs.

For many reasons, some of it greed due to lack of competition, there have been shortages of old generic drugs; along with the short supply, lack of drugs for serious illnesses and, at least in some cases, exorbitant prices. There have been long-standing shortages of penicillin G, gentamicin, some vaccines and some antiparasitic drugs. Many factors contribute to these shortages, but one reason is clearly the financial incentives for industry to develop blockbuster new and expensive drugs, especially for chronic diseases. There is little incentive to revive old generic drugs.

This is different from the well-publicized “pay for delay” tactic, in which branded drug producers delay competition from generic drug manufacturers when branded drugs go off patent by paying them to delay manufacture. The drugs being discussed here have long been off patent.

Donald Kaye

Donald Kaye

In the past several years, there have been significant shortages of antituberculosis drugs, to the extent that treatment programs have had to modify their approach to prevention and treatment of TB. This includes first-line anti-TB drugs, such as isoniazid and rifampin, and second-line drugs, such as streptomycin, cycloserine (Seromycin, Purdue GMP), ethionamide (Trecator, Wyeth Pharmaceuticals), rifabutin (Mycobutin, Pharmacia and Upjohn), amikacin, capreomycin (Capastat Sulfate, Akorn) and kanamycin. Injectable generic rifampin is in short supply and therefore the price has gone from $25 a vial for the generic to $150 a vial for the branded product.

Effect on patients

TB is clearly an infection to be taken seriously. These shortages affect the health care of the patients, as well as on the public health system in the United States, and we cannot allow this to happen. Some other drugs in short supply are the following parenteral anti-infective drugs: acyclovir, cidofovir, ticarcillin-clavulanate and tobramycin.

Another striking example of this phenomenon, and the latest example of which I am aware, is the case of doxycycline. Earlier this year, doxycycline mysteriously disappeared from the supply chain in the United States and then reappeared at a cost of at least 20-fold higher than before. Not long before the disappearance, the cost to hospital pharmacies was about $10 for 50 pills of 100 mg doxycycline; it then jumped to a staggering $250 for 50 pills.

Retail pharmacies were charging more if they could even obtain the drug. I cannot trace the reason for the shortage of doxycycline or the unbelievable jump in price, but occurrences like this have to be part of the problem of the cost of medical care in the United States. Doxycycline is an old generic drug that is the oral drug of choice for Lyme disease, as well as other indications; it has been inexpensive up to now. Some entity must be taking advantage of the population requiring this drug. I have neither heard nor read of any widespread indignation over this. When a reason is given for the shortage, some of the suppliers cite a shortage of raw materials; too much demand; fewer companies producing product; and manufacturing issues.

Shortage across specialties

The short supply phenomenon of cheap generic drugs is not restricted to anti-infectives. The same thing has occurred with drugs such as those used to treat attention-deficit/hyperactivity disorder, in which there is a shortage of cheaper drugs. Also, through some fluke regulation, generic colchicine is no longer available in the United States, and only much more expensive branded colchicine can be obtained. Certain oncology drugs, especially injectable ones, are in short supply. I am certain that there are many other examples of this, but being limited mainly to infectious diseases, I cannot elaborate further.

Despite the shortages in the United States, these drugs are often available at reasonable prices in other locations such as Canada and in Europe. Of course, these supplies are not readily available to us by legal means, and efforts are being made to choke off that potential supply to US residents.

Probably in response to the IDSA’s call for “New Drugs for Bad Bugs,” the federal government has used public funds to entice pharmaceutical companies to develop new antibiotics. It seems that we also need either regulation or financial incentives to get the pharmaceutical companies to continue to provide adequate supplies of important generic drugs at appropriate prices.

I would like to see a ground swell of anxiety by national organizations such as the IDSA to try to rectify this situation. How about something like, “Important Bugs; Where Are the Generic Drugs?”

References:

CDC. MMWR. 2013;62:398.
CDC. MMWR. 2013;62:23-26.

For more information:

Donald Kaye, MD, is a professor of medicine at Drexel University College of Medicine, associate editor of ProMED-mail, section editor of news for Clinical Infectious Diseases and is an Infectious Disease News Editorial Board member.

Disclosure: Kaye reports no relevant financial disclosures.

The Infectious Diseases Society of America has adopted and popularized the mantra of “Bad Bugs, No Drugs” for good reasons. However, there is another very significant problem occurring of shortages of old generic drugs.

For many reasons, some of it greed due to lack of competition, there have been shortages of old generic drugs; along with the short supply, lack of drugs for serious illnesses and, at least in some cases, exorbitant prices. There have been long-standing shortages of penicillin G, gentamicin, some vaccines and some antiparasitic drugs. Many factors contribute to these shortages, but one reason is clearly the financial incentives for industry to develop blockbuster new and expensive drugs, especially for chronic diseases. There is little incentive to revive old generic drugs.

This is different from the well-publicized “pay for delay” tactic, in which branded drug producers delay competition from generic drug manufacturers when branded drugs go off patent by paying them to delay manufacture. The drugs being discussed here have long been off patent.

Donald Kaye

Donald Kaye

In the past several years, there have been significant shortages of antituberculosis drugs, to the extent that treatment programs have had to modify their approach to prevention and treatment of TB. This includes first-line anti-TB drugs, such as isoniazid and rifampin, and second-line drugs, such as streptomycin, cycloserine (Seromycin, Purdue GMP), ethionamide (Trecator, Wyeth Pharmaceuticals), rifabutin (Mycobutin, Pharmacia and Upjohn), amikacin, capreomycin (Capastat Sulfate, Akorn) and kanamycin. Injectable generic rifampin is in short supply and therefore the price has gone from $25 a vial for the generic to $150 a vial for the branded product.

Effect on patients

TB is clearly an infection to be taken seriously. These shortages affect the health care of the patients, as well as on the public health system in the United States, and we cannot allow this to happen. Some other drugs in short supply are the following parenteral anti-infective drugs: acyclovir, cidofovir, ticarcillin-clavulanate and tobramycin.

Another striking example of this phenomenon, and the latest example of which I am aware, is the case of doxycycline. Earlier this year, doxycycline mysteriously disappeared from the supply chain in the United States and then reappeared at a cost of at least 20-fold higher than before. Not long before the disappearance, the cost to hospital pharmacies was about $10 for 50 pills of 100 mg doxycycline; it then jumped to a staggering $250 for 50 pills.

Retail pharmacies were charging more if they could even obtain the drug. I cannot trace the reason for the shortage of doxycycline or the unbelievable jump in price, but occurrences like this have to be part of the problem of the cost of medical care in the United States. Doxycycline is an old generic drug that is the oral drug of choice for Lyme disease, as well as other indications; it has been inexpensive up to now. Some entity must be taking advantage of the population requiring this drug. I have neither heard nor read of any widespread indignation over this. When a reason is given for the shortage, some of the suppliers cite a shortage of raw materials; too much demand; fewer companies producing product; and manufacturing issues.

Shortage across specialties

The short supply phenomenon of cheap generic drugs is not restricted to anti-infectives. The same thing has occurred with drugs such as those used to treat attention-deficit/hyperactivity disorder, in which there is a shortage of cheaper drugs. Also, through some fluke regulation, generic colchicine is no longer available in the United States, and only much more expensive branded colchicine can be obtained. Certain oncology drugs, especially injectable ones, are in short supply. I am certain that there are many other examples of this, but being limited mainly to infectious diseases, I cannot elaborate further.

Despite the shortages in the United States, these drugs are often available at reasonable prices in other locations such as Canada and in Europe. Of course, these supplies are not readily available to us by legal means, and efforts are being made to choke off that potential supply to US residents.

Probably in response to the IDSA’s call for “New Drugs for Bad Bugs,” the federal government has used public funds to entice pharmaceutical companies to develop new antibiotics. It seems that we also need either regulation or financial incentives to get the pharmaceutical companies to continue to provide adequate supplies of important generic drugs at appropriate prices.

I would like to see a ground swell of anxiety by national organizations such as the IDSA to try to rectify this situation. How about something like, “Important Bugs; Where Are the Generic Drugs?”

References:

CDC. MMWR. 2013;62:398.
CDC. MMWR. 2013;62:23-26.

For more information:

Donald Kaye, MD, is a professor of medicine at Drexel University College of Medicine, associate editor of ProMED-mail, section editor of news for Clinical Infectious Diseases and is an Infectious Disease News Editorial Board member.

Disclosure: Kaye reports no relevant financial disclosures.