The Promoting Innovation and Access to Life-Saving Medicine Act

By: Scott Hoffman, CIS Associate
scotthoffman@cis-partners.com

As I am sure everyone reading this is aware, one of the key goals of the Obama administration is to bring affordable healthcare to all Americans, and the administration is currently working on a variety of initiatives to ensure that goal comes to fruition. One of the initiatives being brought to the floor is the “Promoting Innovation and Access to Life-Saving Medicine Act,” which is sponsored by Representatives Henry Waxman, Frank Pallone, Nathan Deal, and Jo Ann Emerson. The overall goal of this bipartisan act is to allow the Food and Drug Administration (FDA) to approve affordable copies of biotech drugs, as the FDA currently lacks clear authority to approve generic versions of these products, allowing companies to charge monopoly prices even after all patents have expired [1]. Rep. Deal stated,

While biologics are highly effective medications in the treatment of a host of
debilitating and life-threatening medical conditions, biologic drugs often cost
on average 22 times more per daily dose than chemical medications, the most
expensive of which costs well over $100,000 per year. It is expected
approximately 50% of all drugs approved in 2010 will be a biopharmaceutical, a
projection which only underscores the need for this legislation as the strain on
state and federal governments grows [1].

Under the current rules, biotech producers are able to make minor structural changes to their existing patented products, allowing them to obtain additional periods of exclusivity, which in turn allow the producers to continue to charge “monopoly prices” [1]. This process, referred to as evergreening, is addressed in this act by allowing generic manufacturers to produce “biosimiliar” products. A biosimiliar product is considered to have no clinically meaningful difference between the biological product and the original product in terms of the safety, purity, and potency [2]. However, in order for the FDA to approve a biosimiliar product, the application must demonstrate the following:

• The product is highly similar in structure to the original product;
• No clinically meaningful differences between the products are expected;
• The two products have the same mechanism of action, if known;
• The proposed product label carries one or more of the approved indications for the original product;
• The route of administration, dosage form, and strength, are the same as the original product; and
• The controls used in manufacturing the product are adequate to assure identity, strength, quality, and purity [2].

The act contains an additional stipulation for FDA approval of a biosimiliar drug; it must also be interchangeable, which means the risk of switching the patient one or more times between the original product and the biological product can be expected to be not significantly greater, in terms of safety or diminished effectiveness, than the risk of continuing to use the original product without such switching [2]. In order to prevent delays in the FDA approval of biosimiliar products, the act stipulates that the FDA must approve or disapprove the application for a comparable biological product within ten months after submission, or 180 days after the application is accepted for filing by the FDA, whichever is earlier, unless the final action date is extended by joint agreement of the applicant and the FDA [2].

Currently, the bill has a wide range of support from consumer groups, businesses, unions, patient groups and payers. Additionally, there is an expected companion Senate bipartisan bill being introduced by Senators Chuck Schumer, Susan Collins, Sherrod Brown, and David Vitter [1]. As this bill comes to vote on the floor it will be interesting to see how both the House and the Senate vote, as this legislation could set a framework for future bills on generic chemical drugs, as well as potential stem cell based drugs, in the future.

Sources:
[1] http://energycommerce.house.gov/index.php?option=com_content&task=view&id=1528&Itemid=1
[2] http://energycommerce.house.gov/Press_111/20090311/hr1427_detailedsummary.pdf