Drug shortages continue to affect ovarian cancer patients in the United States. The Ovarian Cancer National Alliance has been tracking this issue closely and working with stakeholders and patients to identify solutions. We will continue to update our community as new information becomes available. Below are critical updates from the past two weeks.
Women with ovarian cancer have been especially affected by shortages of Doxil. Jannsen announced this weekend that the next batch of Doxil will be available in approximately six weeks (mid-November). However, this batch is not expected to meet the needs of all patients enrolled in the Doxil CARES Access Program.
On September 26, Alliance staff participated in an all-day workshop about drug shortages hosted by the Food and Drug Administration (FDA). Numerous stakeholders shared their experience with drug shortages and discussed the causes. Patients, manufacturers, distributors and providers presented a picture of missed treatments, less than ideal treatments and problems ensuring safety of drugs.
Stakeholders at the FDA meeting indicated that most of the drugs affected by this national shortage are the older, generic drugs that are the mainstays of treatment. Further, insurers are pushing back at covering treatment options that do not follow protocol, even if those protocols cannot be followed due to shortages. These shortages are also affecting clinical trials, because often the standard treatment arm is not available or cannot be delivered on time. This stops enrollment in a clinical trial, and for those that are continuing, it will be difficult to determine any benefits of the experimental arm.
The House Energy and Commerce Committee held a hearing on Friday, September 23, that discussed the cause and effect of shortages. The majority of drug shortages are due to quality issues, ranging from those that can be resolved to severe problems that have shut down plants. Many speakers discussed finding shards of glass or metal shavings in infusion products. Additionally, consolidation in the industry has reduced capacity and redundancy, so that if one manufacturer cannot produce a drug, no other facility is able to step in and make that drug. The witnesses did not directly address pricing of generic drugs, and none said that price affected their interest in manufacturing a drug. Nonetheless, some manufacturers have discontinued drugs.
The Committee was especially interested in price and quality concerns that arise when drugs are sold on the so-called “gray market.” This is when a provider or hospital buys drugs from an organization other than a licensed distributor or the company that manufactured the drugs. It is difficult to know where gray market drugs are manufactured and whether they meet quality standards. Further, drugs can be marked up as much as 1,000 percent when sold on the gray market.
Neither the FDA workshop nor the Committee hearing produced actionable solutions.
A bill has been introduced in the House and Senate that requires manufacturers to alert the FDA six months in advance of any production stoppages. Many believe this is important, but only as a first step. The Alliance has endorsed this bill.
The Government Accountability Office (GAO) will be releasing a report this fall that is expected to be the definitive authority on the problems leading to current shortages.
The Alliance will be holding a meeting on October 3 aimed at producing solutions in advance of the GAO Report. We continue working with patients, advocacy groups, pharmaceutical companies and contract manufacturers to ensure women are getting the medical care they need.
FACTS FROM THE HEARINGS
- Of the 4 billion prescriptions filled in the United States in 2010, 3 billion were generic drugs
- 54 percent of shortages are due to quality control issues
- 21 percent of shortages are due to delays in manufacturing or capacity issues
- The integrity or safety of drugs sold on the gray market cannot be assured
- The average mark up of drugs on the gray market is 650 percent; one-quarter of drugs sold on the gray market are marked up 2000 percent
- 99 percent of hospitals report experiencing one or more drug shortage in the first six months of 2011
- 66 percent of hospitals report an oncology drug shortage
- In an April 2011 survey, more than 90 percent of anesthesiologists reported at least one drug shortage at the time of the survey and 98 percent reported a shortage at some time during the past year
- The shortages have cost hospitals $415 million in drug and labor costs