Open Season: How Can Makers of Biologic Drugs Navigate the Current Political Climate?


biologic drugs
The current political climate has put additional pressure on manufacturers of biologic drugs.
Image source: Flickr CC user oliver.dodd

Politicians have never been shy about picking targets upon which to build platforms or make their pet issues. Unfortunately, due to rising healthcare costs and the public perception of drug prices, the pharmaceutical industry has become an easy target. The pressure upon lawmakers to do something has become enough that even presidential hopefuls who have traditionally supported the pharmaceutical industry have taken to attacking manufacturers of biologic drugs and other medical therapies. It is perhaps not the most surprising turn of events, but the added attention puts companies in an awkward position.

To further complicate matters, legislators aren’t waiting until after the upcoming Presidential election to take action. The future of the Trans-Pacific Partnership remains uncertain1, but Congressional committees are ramping up industry oversight. Both the House and Senate has dedicated resources toward investigating pricing practices and taking action to curtail rising costs.2 The increased scrutiny has cast a shadow over recent successes of the pharmaceutical industry—namely that we’ve seen the accelerated development of major new therapies. In 2014, the FDA approved 41 new drugs, 10 of which were biologic drugs.

A Hostile Political Climate Means Makers of Biologic Drugs Need to Justify Costs to Sway Public Opinion

With the spotlight shining on the prices of new drugs, life sciences organizations will need to be even more scrupulous in their R&D efforts. By focusing on the ability to maintain streamlined and efficient release cycles, they can support more market-ready products given regulatory approval and thereby demonstrate good faith to lawmakers.

While makers of biologic drugs should do their best to curtail rising costs without sacrificing margins, their primary aim needs to remain upon developing innovative, life-saving drugs. In recent years, we’ve seen the FDA approve groundbreaking biopharmaceuticals geared toward improving the quality of life for various patient demographics. They need to carry on that legacy into the future, continuing their role as the central drivers of discovering and developing new treatments. By concentrating on therapies deemed necessary in the public eye, life sciences companies can bolster their market standing and improve their reputations, which can help justify R&D costs as unavoidable and acceptable. Since political pressure is often the result of public opinion, currying favor from the general populace can pave the way for a future more favorable toward the pharmaceutical industry. Presently, smaller biopharmaceutical companies are driving this movement, but larger organizations should not allow themselves to be left behind. They can follow their competitors’ example by diversifying their catalog of biologic drugs during the R&D phases.

In addition to drug pricing, legislators and regulatory bodies are also turning their eye upon manufacturing practices. As their interest grows, life sciences organizations will need to ensure they’ve implemented solutions that support the development and manufacturing of biologic drugs with clear quality guidelines. Not only that, their efforts must remain compliant with regulatory guidelines via periodic review. After all, a large part of scrupulous practice consists of the ability to report the necessary metrics, to prove that all requirements are being followed in the first place.

No matter the result, the next few years are sure to be an interesting period in U.S. political history. To weather the storm, life sciences companies that specialize in developing biologics drugs and other pharmaceuticals will need to make sure they remain steadfast in the face of a highly critical public that has made them into an easy target for politicians jockeying for advantage. One way to do that is by ramping up efforts to be streamlined, efficient, and scrupulous in their R&D practices.

The BIOVIA Biologics Solution is a comprehensive set of tools developed to support life sciences organizations in the discovery and manufacturing of biologic drugs. Through a common platform, the solution optimizes both the development of biotherapeutic candidates and the overall workflow surrounding the release cycle. Its capabilities support various crucial tasks such as data management and analysis of quality metrics, which contribute to boosted efficiency and innovation. If your life sciences organization is interested in adopting an integrated solution to help its R&D efforts, please contact us today to learn more.

  1. “Speaker Ryan: Not enough votes for TPP trade deal,” February 11, 2016,
  2. “Pharma Caught in Political Crosshairs,” December 2, 2015,