Steps to Improve Competition in the Prescription Drug Marketplace

BIOtech Now
Andrew Segerman

Recently on BIOtechNOW, we shared Three Encouraging Steps on Prescription Drug Costs which looked at recent efforts by policymakers to help ensure the medicines patients need are accessible and affordable. But these aren’t by any means the only steps being taken to address the affordability of prescription drugs. In fact, policymakers, along with stakeholders across all health care sectors are working hard to increase access to lower-cost alternatives that consumers and patients can count on:

Competition in any given market naturally helps drive down prices. This fact is no less true in the prescription drug market – and the FDA is leading the way. In a recent Wall Street Journal article, reporter Charley Grant points out:

“[T]he Food and Drug Administration is bringing in more competition to the drug business. …  One reason for the falling prices is a faster pace of generic drug approvals by the FDA. Dr. Scott Gottlieb, who took over as commissioner in May, vowed to quicken the pace in a bid to encourage competition.”

And Grant’s point is valid. Regulatory Affairs Professional Society confirmed this information citing FDA data in early October:

“US Food and Drug Administration (FDA) has approved more abbreviated new drug application (ANDA) in 2017 than any other year, according to the latest FY 2017 activities report. … The 763 approvals (or 927 approvals and tentative approvals) is 112 more generic approvals than last year, which set the previous record for the highest tally in a year, and 271 more than 2015 and 354 more than in 2014.”

Smart policy that promotes a competitive market for treatments and cures is key to making health care affordable. That’s why the President signed into law the Food and Drug Administration Reauthorization Act (FDARA) this past summer which includes the reauthorization of the Generic Drug User Fee Amendments (GDUFA). Included in the law are reforms that will expand access to safe, high-quality, and affordable generic drugs for American patients. As FDA experts Drs. Kathleen Uhl and Michael Kopcha explained in October:

“Congress first approved the collection of user fees from industry to help fund FDA’s generic drug program in 2012 – for a five-year period.  Having another source of funding beyond our traditional budget appropriations from Congress for an extended period of time allowed us to hire additional staff and to better allocate our review activities.

“As a result, FDA approved record numbers of generic drug applications. In fact, 25 percent of all generic drugs currently approved were approved during the first five years of GDUFA. In the last two years of GDUFA, the FDA approved more generic drugs each year than in any other year in the history of the generic drug program. The reauthorization of GDUFA will help us build on this success.”

Stakeholders agree: competition is a key to making health care work. We can all agree that there is no “magic wand” to lowering health care costs, but promoting sustainable reforms focused on maintaining a competitive market that offers consumers and patients greater access to generic products is a great start. And as we’ve seen from the Council for Affordable Health Coverage – a group of pharmacy benefit managers, drug manufacturers, insurers, patients, consumers and employers – we can achieve this goal by bringing together stakeholders from all health care sectors.

“Enhancing competition in the market gives us our best opportunity to lower drug prices,” BIO CEO Jim Greenwood recently noted.

Policymakers are taking important steps to ensure patients have access to affordable, innovative treatments that they need. Rather than undermining the progress we’ve made, let’s build upon and strengthen our work that has proven to be effective.

Full BIOtech Now Article here

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