|
 The drug is now sold at a list price of $375,000 a year by Catalyst
Pharmaceuticals under the brand name Firdapse. It is used to treat
Lambert-Eaton Myasthenic Syndrome (LEMS), which affects about one in
100,000 people in the United States.
Florida-based Catalyst received Food and Drug Administration
approval for Firdapse in November, along with exclusive rights to
market the medication for several years. The drugmaker, in response
to a recent query from Senator Sanders, said its prices are in line
with similar products in the industry.
Before the launch of Firdapse, patients were able to get the same
drug for free from Jacobus Pharmaceuticals, a small New Jersey-based
drug company, which offered it through an FDA program called
"compassionate use."
The program allows patients with rare diseases and conditions access
to experimental drugs outside of a clinical trial when there is no
viable alternative.
In the Feb. 26 letter, Senator Sanders, citing the Catalyst drug's
"shocking price," called on FDA Commissioner Scott Gottlieb to
announce that the agency will not take enforcement action against
pharmacies and manufacturers that were previously providing the drug
to patients. Sanders also gave the letter to Health and Human
Services Secretary Alex Azar in a private meeting on Tuesday.
FDA spokeswoman Jennifer Rodriguez, in an emailed statement, said
the FDA has received the letter and will respond directly to the
senator. HHS also said it has received the letter and will respond.
In 2012, a federal judge dismissed a lawsuit brought by K-V
Pharmaceutical Co against the U.S. government seeking to ban sales
by pharmacies of cheaper, unapproved versions of its premature birth
drug Makena - which the FDA had allowed after public outcry over the
high price of the newer drug.
[to top of second column] |
FDA approval of Makena came years after pharmacies had already been
compounding such a drug at far lower prices than Makena, using an
active ingredient, hydroxyprogesterone, available without formal FDA
approval.
"Catalyst may be the most recent company to exploit their monopoly
after receiving FDA approval for an inexpensive old drug, but they
were certainly not the first," Sanders said in the letter.
He noted the prices of very old and inexpensive drugs like
colchicine, vasopressin, neostigmine, and others have been raised
substantially by drugmakers following FDA approval, causing needless
suffering and adding to the cost of health care.
The government is intensifying its scrutiny of the pharmaceutical
industry and rising prescription drug prices, a top voter concern
and a priority of President Donald Trump's administration.
Both the Democratic-led House of Representatives and the Senate,
controlled by Republicans, have begun holding hearings this year on
the rising costs of medicines. Sanders is an independent who usually
votes with Democrats.
(Reporting by Deena Beasley in Los Angeles; Editing by Michael
Perry)
[© 2019 Thomson Reuters. All rights
reserved.] Copyright 2019 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed.
Thompson Reuters is solely responsible for this content.
 |
