CREATES Act Introduced

We’ve previously told you about ways by which outdated regulations make it harder for consumers to get affordable prescriptions and place more of a burden on taxpayers. Writing in Roll Call, Jonathan Bydlak ran down some of the most common ways this occurs:

Americans are rightfully concerned with rising medical costs, but some of the ways by which costs rise can be tedious and difficult to understand for those not already familiar with broader regulatory issues.

What’s going on, though, is actually pretty straightforward: Brand-name producers regularly take advantage of systems designed to protect consumers to instead protect their bottom lines and crush out competition from their generic competitors.

One common way by which anti-competitive behavior occurs is by preventing access to the materials needed to test generic or biosimilar alternatives.

In other words, pharmaceutical companies refuse to let competitors prove their safety, and then enjoy the monopoly that results when theirs are the only drugs proven to be safe. While the Food and Drug Administration rules in question legally cannot be used to stifle competition, the FDA itself admits that intentional stifling does occur.

Another common monopoly-creating behavior is when brand-name companies refuse to let generic competitors participate in certain shared safety protocols used to prove that drugs are safe. Again, these procedures, originally established to protect patients, are being used to prevent access to affordable options.

The FAST Generics Act took on some of these issues, and now, the CREATES Act, which also aims to address anticompetitive behavior has been reintroduced in the House and Senate last week. Senators Grassley, Leahy, Lee, Klobuchar, Cotton, Whitehouse, McCain, Blumenthal, Collins, McCaskill, Durbin, and Feinstein are currently sponsoring this bipartisan legislation, while Reps. Marino and Cicilline lead the effort in the House.

We’re thrilled to see commonsense and cost-saving regulatory reform making progress, and fiscal conservatives should keep a close eye as these reforms develop further.