Delay in Generic Hepatitis C Treatment Approval Leaves Patients in Need

Strategic Insights -

The patent on Rebetol, a drug used to treat hepatitis C, expired in June, but a generic version of the medicine has yet to receive FDA approval due to a dispute over the drug's label. Three Rivers Pharmaceuticals, the company seeking to sell the generic version, filed an application with the FDA 17 months ago, but the delay has left patients with the disease in a precarious position, as many cannot afford the $20,000 cost of treatment. Regulators are caught in a quagmire, fearing lawsuits from Schering-Plough, the manufacturer of the brand-name version, if they allow the generic label to differ from the brand's. This is not an isolated issue, as experts say that drug companies are increasingly using labeling as a means to block lower-cost competition.

Key Takeaways:

  • The FDA has been holding up the approval of a generic version of Rebetol, a hepatitis C treatment, due to a dispute over the drug's label.
  • Three Rivers Pharmaceuticals, the company seeking to sell the generic version, filed an application 17 months ago, but the delay has left patients in need of affordable treatment.
  • The FDA is caught in a bind, fearing lawsuits from Schering-Plough, the manufacturer of the brand-name version, if they allow the generic label to differ from the brand's.
  • Drug companies are increasingly using labeling as a means to block lower-cost competition.
  • Experts say that the FDA is aware that any move they make will likely be met with lawsuits from one side or the other.
  • The delay in approval is particularly frustrating for patients, as many cannot afford the $20,000 cost of treatment for hepatitis C.
  • The lack of F.D.A. approval is slowing the litigation between Three Rivers and Schering-Plough, with Schering arguing that Rebetol is still protected by various patents.
  • The company Schering-Plough has at least eight patents protecting Rebetol, many of which were added in the last two years.
  • Schering has argued that the F.D.A. should not approve the generic version because it has not cleared all patents, a claim that experts say is a delay tactic.
  • The current recommended treatment for patients with hepatitis C is ribavirin combined with peginterferon alfa, which can cost up to $30,000 for a year's treatment.

Statistics:

  • The government approves brand name drugs in about 14 months, while generic drug approvals take roughly 18 months, according to F.D.A. statistics.
  • The FDA approved 384 generic drug applications in 2002, up from 307 in 2001.
  • More than four million Americans are infected with hepatitis C, and many of them are H.I.V.-positive.
  • The virus causes an estimated 8,000 to 10,000 deaths each year in the United States.
  • Rebetol can cost an uninsured patient as much as $20,000, while ribavirin, the generic version, is relatively inexpensive to manufacture, with a price of $1.50 a capsule.

Sources:

  • "When Brand-Name Drugs Become Too Pricey," _The New York Times_, February 12, 2003
  • "A Rule Change for Prescription Drugs," _The New York Times_, February 12, 2003
  • "Experts Say New Rules Will Speed Approval of Generic Drugs," _The New York Times_, January 28, 2002
  • "Treatment for Hepatitis C: The Goals Are Clear, but the Price Is High," _The Washington Post_, February 13, 2003