Drug Shortages Impacted by Many Factors

The prescription drug shortages are the result of a number of circumstances, policies, and events. Unfortunately, the implications of these shortages are increasingly affecting patient's well- being and health outcomes.

There are so many considerations and factors influencing the drug shortage situation in the U.S. that it is difficult to fully cover each. Patient groups are advocating for those without access to important or even life-saving therapies; pharmacy groups are reporting that shortages are driving up drug costs as characterized in this  Drug Topics article; drug manufacturers contend that the shortages, for certain drugs, are driven by DEA efforts to prevent drug abuse and misuse. The pharmaceutical companies indicate that for controlled drugs, limitations upon how much of a particular controlled substance can be manufactured have exacerbated drug shortages.

Reactions to Draft Guidance on Biosimilar

Comments are being accepted regarding the February 9, 2012 release of FDA Draft Guidance on Biosimilar product development. In total, there are three draft documents. There is some concern amongst manufacturers that the guidelines include many caveats. There's a general sense that the guidelines are developed form a conservative perspective. We will update as the guidelines are revised and finalized. In the meantime, http://aishealth.com/archive/nref022712-06 considers the guidelines in further detail.

The agency proposed three user fee programs to Congress earlier this month.

Our Take: The programs include the fifth authorization of the original Prescription Drug User Fee Act (PDUFA) as well as the new generic and biosimilar programs. The recommendation were sent to Congress, but there's been little published to date about their status. We'll keep you posted as they are considered and information becomes available.  

The order, signed this week by President Obama, directs the FDA to expedite reviews of applications for drugs in short supply.

Our Take: The lack of availability of medications has hit record levels. In 2010 there were 178 shortages reported by the FDA, and the number is projected to be higher in the current year. There appear to be many factors at play. In addition to supply side issues, such as meeting regulatory requirements and raw material availability issues, there are also complex business dynamics at play. Many of these treatments are not considered highly profitable, since they are available as generic products.

Some manufacturers have run into regulatory problems, which have shut down or delayed the production and availability of certain products. Others are making business decisions regarding the "best" use of resources. Often they are seeking to produce more profitable products when a choice exists. The executive order, suggests that reviews be expedited. While it's possible this will help to some extent, it is not likely to be the full solution. Read more in these articles published in Bloomberg, The Hill, and Politico, along with other sources.

The new drug combines the cholesterol treatment, simvastatin, with diabetes therapy, Januvia.

Our Take: Identified as a combination treatment intended to improve adherence, the combination drug will likely be marketed as beneficial for patients with type 2 diabetes who are in need of cholesterol lowering treatment. In terms of costs, value will need to be assessed. Of note, the anti-diabetic treatment, Januvia, continues to have patent protection until 2017.

The FDA is charged, by law, with developing a national standard for tracking drugs. However, the agency is not empowered to enforce those standards.

Our Take:  As Congress prepares to reauthorize The Prescription Drug User Fee Act, effective through September of 2012, the prospect of tracking raw materials and increasing inspections in foreign manufacturing facilities is being explored. The initiatives are being considered as a means of helping to address recurring problems with prescription drug diversion and quality.  Those issues often lead to other problems, including drug shortages which may affect the ability to adhere to drug treatment protocols, impacting patient outcomes and quality of care.

In some instances shortages lead to treatment with costly alternative therapies, while in other cases contamination or mishandled drugs adversely impact patient well being or outcomes. The extreme scenario here might be the heparin contamination case. The issue is under consideration and the Pink Sheet explores the subject further.

Our Take: Talks are ongoing, but the industry and the agency have agreed that companies would pay up to $299 million to speed up drug approvals and help cover the costs associated with inspection of foreign drug manufacturing facilities. The FDA does collect similar fees from branded drug manufacturers. The concept of user fees is also on the table in talks regarding the approval of generic biologic drugs. Of course, it's reasonable to anticipate these fees will be seen as an element of drug costs.

The  agency will have drug makers modify drug labeling for erythropoesis stimulating agents.

Our Take: The agency is making the changes in an attempt to promote conservative dosing of the drugs and to limit the likelihood of adverse reactions. ESA's are often used for the treatment of anemia in patients with chronic kidney disease. CMS issued a statement indicating it will not issue a national coverage determination at this time.

Our Take: The agency has faced an uphill battle in regulating advertising and promotional messages for some time. Technology has advanced at a rate that has outpaced the development and release of guidelines and regulations.

Additionally, the "standard" for determining whether a promotional message was considered defensible, has, for some time, been the existence of a published study in a refereed medical journal. Over the past several years the playing field has been changed, dramatically. Internet promotions are widely unregulated, and the source and quality of articles having appeared in medical journals has been questioned. Some studies have allegedly been drafted by paid "ghost writers" rather than researchers.

This article, published by Reuters features the preliminary results of a new initiative, the FDA's "Bad Ad" Program. Intended to provide a portal for reporting of questionable promotional strategies, through this undertaking the FDA has received 328 reports of potentially questionable marketing strategies, of which 87 were considered worthy of further investigation.

Our Take:  Perspective as to the benefits of Comparative Effectiveness Research varies, with some supporting as well as opposing the concept. However, both camps tend to agree that a major limitation to applying CER is the lack of data.

A recent article in the Journal of the American Medical Association suggests that much data might already be available in the public domain in the form of studies submitted to the FDA. The authors suggest that while the data is a source, it must be assessed for relevance, but could still serve as a possible starting point for coverage decisions. AIS Health News explores the topic further.