HHS, FDA and CMS Leaders Emphasize How Streamlining Biosimilar Approvals Will
Strengthen Competition, Expand Access and Deliver Savings for Patients and the
U.S. Health Care System





 



THEY SAID IT!: ADMINISTRATION HIGHLIGHTS HOW BIG PHARMA GAMES THE SYSTEM TO
UNDERMINE BIOSIMILAR COMPETITION, KEEP PRESCRIPTION DRUG PRICES HIGH

HHS, FDA and CMS Leaders Emphasize How Streamlining Biosimilar Approvals Will
Strengthen Competition, Expand Access and Deliver Savings for Patients and the
U.S. Health Care System



In case you missed it, U.S. Department of Health and Human Services (HHS)
Secretary Robert F. Kennedy Jr., U.S. Food and Drug Administration (FDA)
Commissioner Dr. Marty Makary and Centers for Medicare & Medicaid Services
(CMS) Administrator Dr. Mehmet Oz last weekannounced
<[link removed]>
reforms to accelerate biosimilar approvals — an important step toward
fostering greater competition from more affordable alternatives to Big Pharma’s
high-priced brand name biologics and lowering prescription drug prices.



The announcements included commitments to update FDA guidance to eliminate
comparative efficacy study requirements and streamline biosimilar approvals — a
move that could significantly reduce barriers to fostering greater competition
from more affordable alternatives to high-priced biologic drugs. The FDA also
signaled support for automatically designating all biosimilars as
interchangeable with their reference products and taking steps to increase
domestic biosimilar manufacturing.



Here are some highlights of what these health care leaders in the
administration had to say during the announcement, including highlighting how
Big Pharma’s patent abuse is a root cause of high prescription drug prices in
the United States:



U.S. Secretary of Health and Human Services Robert F. Kennedy Jr.: “When
Congress wrote the Biologics Price Competition and Innovation Act, the
pharmaceutical industry rigged the rules. Between 2007 and 2009, Big Pharma
spent hundreds of millions of dollars lobbying to make biosimilar approval far
more difficult and expensive… The result has been sky-high costs, endless red
tape and a biosimilar market that still lags far behind Europe’s. That changes
today… Today, the FDA is taking bold and decisive action to break down these
barriers and open the markets for real competition. The agency will release new
draft guidance for companies developing biosimilars, guidance that reflects
modern science and common sense… The result will be more competition, lower
prices and faster access to life-saving medicines.”



U.S. Food and Drug Administration Commissioner Dr. Marty Makary: “The fastest
growing area of healthcare spending in the United States is drug spending, and
the fastest area of drug spending increases is with this new class of medicines
called biologics… Think of biosimilars as the generic version of the expensive
biologics. We have 76 that we’ve approved in 10 years; it probably should have
been 200 or 300. But there’s a series of onerous requirements that the FDA has
had, making the process long and expensive for the makers of these biosimilar
equivalents… Today, the FDA is issuing draft guidance to eliminate the onerous
requirement of comparative studies that have historically been associated with
biosimilars and their approval… This reform will take the five-to-eight-year
time frame to bring a biosimilar to market and cut it in half… When the first
biosimilar came on the market seven years after Humira’s patent expired, prices
really didn’t go down. Call it an implied collusion of prices. But it takes
typically until two or three biosimilars to come to market to see the prices
really drop. That’s why we need to reduce the hurdles and get more biosimilars
on the market.”



U.S. Centers for Medicare & Medicaid Services Administrator Dr. Mehmet Oz: “If
you’ve got 20 years on a patent, and let’s say 12 years after your biologic is
approved, you should be allowed to recoup that money in that period of time.
But once that patent is over, insurgents should be allowed to enter the
marketplace to appropriately compete. That’s what the ecosystem of fairness
should represent. That’s what’s been hindered with this 40-year history of
one-by-one having to break through barriers, with this being one of the largest
and perhaps the final major barrier to ensure that what started with the
Hatch-Waxman Act can now reach fruition and allow the intent of Congress to be
heard widely, which is that generic products and biosimilars, when they are
appropriately released after patents expire, should allow competition – not
crony capitalism – to run the market. The current system has slowed the ability
of insurgents to enter the market, and that stops today under the leadership of
Dr. Makary.”



Congress should build on this positive momentum from the administration by
advancing bipartisan, market-based solutions, includingThe Affordable
Prescriptions for Patients Act
<[link removed]>
,Q1/Q2 sameness reforms
<[link removed]>
and other solutions with proven support from both sides of the aisle, to crack
down on Big Pharma’s egregious anti-competitive practices.



Read more about the announcement HERE
<[link removed]>
.



Read more about how biosimilar competition lowers out-of-pocket costs for
patientsHERE
<[link removed]>
.



Read more on how Big Pharma games the system to block competition and keep
drug prices highHERE
<[link removed]>
.



Read more on bipartisan, market-based solutions to hold Big Pharma accountable
HERE <[link removed]>.



###

































Copyright © 2019 Campaign for Sustainable Rx Pricing
Our address is 1341 G St NW, #1100, Washington, DC xxxxxx


This email was sent to [email protected]. To unsubscribe please click
here.
<[link removed]>