Month: May 2018

If passed, the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act will permit generic pharmaceutical drug manufacturers to take direct legal action against branded drug manufacturers utilizing improper tactics that diminish fair competition between branded and generic drug manufacturers. While the CREATES Act (H.R. 2212/S. 974) has not yet been passed by Congress, it has bipartisan support in both the House and the Senate and has recently gained momentum.

The CREATES Act aims to decrease drug prices by motivating branded drug manufacturers to provide samples to generic drug manufacturers. In the event branded drug manufacturers do not provide samples, the CREATES Act would allow generic drug manufacturers to file a lawsuit in federal court and a judge would have the authority to require that samples be provided on commercially reasonable, market-based terms.

Generic manufacturers need the branded drug samples for legitimate reasons.  The practice of branded drug manufacturers refusing to provide necessary samples for generic drug manufacturers to understand the formulas for patented drugs and to perform the necessary tests to ensure that generic versions are safe and identical as required by the federal Food and Drug Administration (FDA) allows the branded drug manufacturers to maintain higher prices of the branded versions for their own benefit.  Providing the samples could pave the way for lower drug pricing.

Until recently, momentum has been stalled on this issue. It remains to be seen whether Congress can strike a deal with the branded pharmaceutical industry on this contentious issue

Generic drug manufacturers should contact Frier Levitt Government Affairs today to learn how government affairs and lobbying strategies can be used to promote enactment of the CREATES Act, and should contact Frier Levitt, the law firm, to access branded samples, if the CREATES ACT is passed.

One of the first questions people usually ask when looking for a lobbyist is, “Where is your firm located?” While it makes sense to see whether or not a lobbyist has access to the statehouse at issue, location should not be the sole determining factor when choosing a lobbyist.

The Changing of the Guard in the Lobbying Profession

Traditional lobbying was done by contracted lobbyist who relied solely on past relationships to either pass or stop legislation. Many lobbyists also used campaign contributions as a way to exert influence over a legislator. Often traditional lobbyists lived in the capital or made daily rounds there in hope their presence at the statehouse would help the client gain political advantages. While there may be advantages to these tactics, they not always the most successful ways to get things done.

A new generation of staffers and policymakers are arriving in capitols nationwide and traditional lobbying tactics no longer carry the same weight. The new generation of staffers and policymakers are more interested in one thing in particular: Can I trust the lobbyist to give me good information that tells me both sides of the argument and really understands that issue?

When it comes to Healthcare and Life Sciences, Frier Levitt Government Affairs is able to offer in-depth industry knowledge straight from industry thought leaders with years of hands-on experience. Frier Levitt Government Affairs knows the issues that matter to the Healthcare and Life Sciences industries and is able to build your credibility while offering the best value for your lobbying expenses.

If you are considering hiring a lobbyist in the Healthcare or Life Sciences space, contact Frier Levitt Government Affairs today.