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 week announced 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 The agency will release new draft guidance for companies developing biosimilars, guidance that reflects modern science and common sense… The result will be more competition, lower prices and faster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, including The Affordable Prescriptions for Patients Act, Q1/Q2 sameness reforms and other solutions with proven support from both sides of the aisle, to crack down on Big Pharma’s egregious anti-competitive practices.