A new paper authored by two Food and Drug Administration (FDA) employees argues that the recent spate of drug shortages was caused by numerous factors, all of which can be tied to low prices for the drugs. The lack of adherence to quality standards and low rates of redundancies are directly tied to manufacturer resources. The paper proposes that quality be included in information about the drugs. Much of the recent discussion around drug shortages is related to reimbursement, which is the amount Medicare pays the provider for the drug, rather than price.

The Alliance continues to advocate for access to safe and effective drugs.

Read the paper here

reprinted in part from OCNA

The BRCA1 and BRCA2 mutations are heritable mutations, meaning that a person may inherit them through their mother or father. These genetic mutations can increase a woman’s risk of developing ovarian cancer between 10 and 60 percent.

The case hinged on the difference between nature and invention. The Alliance believes that since these genetic mutations are naturally occurring they should not be patentable; the court, however, ruled that the isolated DNA examined by Myriad is not found in nature. The court specifically stated that these genetic sequences are “prepared from the products of nature [but] so is every other composition of matter” (AMP v. PTO at 39).

The court ruled that isolated DNA is different from naturally occurring DNA, even when it contains the same information, as is the case with the BRCAnalysis test. The Court ruled that “isolated DNA is a tangible, man-made composition of matter defined and distinguished by its objectively discernible chemical structure” (AMP. PTO at 49) and therefore is eligible for a patent.

Sandra Park, staff attorney with the ACLU Women’s Rights Project, argued this case before the Federal Circuit Court. “This is a devastating decision for a woman’s health,” she said. “Patients facing life-changing medical decisions deserve the best quality care and research available. They should not be blocked from getting that care because a company owns the exclusive right to access their genes.”

The Alliance submitted amicus briefs on the case and was present at both Federal Circuit Court oral arguments. Our staff will continue to work with policy makers and payers to ensure that genetic counseling and testing are available as part of the implementation of evidence based guidelines. The Alliance is also working with regulators and industry to ensure that the results of all laboratory tests are accurate and clinically useful.

The case has been contentious, with the Patent and Trademark Office officially being sued for having wrongly granted the patent, and the Solicitor General’s office providing a legal opinion that unmodified DNA is not patent eligible but that DNA that is human engineered is patent eligible. It is highly uncommon for two government agencies to take different public positions on legal proceedings. The case has ramifications for many companies: the Patent and Trademark Office has issued 2,645 patents for isolated DNA in the past 29 years and at least 40,000 patents related to genes in the human genome (AMP v. PTO at 54)

Myriad’s patents on the BRCA1 and BRCA2 mutations expire on December 18, 2015. The ACLU can appeal to the Supreme Court; it has until mid-November to do so.

The House Appropriations Committee recently approved $20 million in funding for the Department of Defense Ovarian Cancer Research Program (DoD OCRP) for fiscal year 2013.  This is an increase from last year’s appropriations of $16 million, but equal to the $20 million funded in FY 2011. Last year the Alliance and MIOCA worked hard to limit that reduction.  We will continue to monitor the appropriations process to ensure the increase to $20 million remains in the final budget.

Drug shortages are affecting patient care across the United States. Many of the medications in short supply are chemotherapy drugs, nutritional supplements and anesthesia drugs. The cause of these shortages is not fully known, but the effect on patients is clear.

Ovarian cancer patients have had reduced access to surgeries and critical drugs needed for treatment. Many women cannot receive standard therapies safely and on time. Many of the standard treatments for ovarian cancer are not available; if women can get drugs, they may not be the standard of care, they may not be available at the right time, or they may be more expensive or less effective drugs. This is unacceptable.

MIOCA is working with the Ovarian Cancer National Alliance and the American Cancer Society to remedy this situation. But we need your help to show our legislators and regulators how drug shortages are affecting women with ovarian cancer. Your stories can persuade and pressure them to act on behalf of patients and put an end to these critical drug shortages. Please contact us to share your story.

reprinted, in part, from OCNA

Washington, DC—The omnibus appropriations bill passed by Congress on December 17 includes funding for three ovarian cancer research and education programs. The Ovarian Cancer National Alliance worked with thousands of advocates across the country to fight for federal funding for these programs. Thanks to these efforts, Congress has made the following appropriations for fiscal year 2012:
$5 million for Johanna’s Law: The Gynecologic Education and Awareness Act, which received no funding in last year’s appropriations bill;
$4.9 million for the Ovarian Cancer Control Initiative run by the Centers for Disease Control and Prevention; and
$16 million for the Ovarian Cancer Research Program (OCRP) run by the Department of Defense.
“This is a tremendous victory for women with ovarian cancer and those who love them,” noted Karen Orloff Kaplan, CEO of the Ovarian Cancer National Alliance. “We were deeply concerned when last year’s bill eliminated funding for Johanna’s Law; early versions of this year’s budget also proposed drastic cuts to ovarian cancer research. Thankfully, our champions in Congress recognized the need to fund these programs.”
“An estimated 15,000 will die from ovarian cancer in 2012,” says Dr. Kaplan. “We rely on federal funding to educate women about the risks, signs and symptoms of this disease, and to support innovative research projects that could lead to an early detection test or better treatments. Women across the nation are breathing a sigh of relief today that critical ovarian cancer research will continue, and educational programs begin anew.”
Representative Dan Burton (R-IN), a leading supporter of ovarian cancer research funding, said: “I am very pleased that the House Appropriations Committee saw fit to secure funding to continue ovarian cancer research and education programs in the Fiscal Year 2012 Omnibus package. Eighty percent of women are diagnosed with this form of cancer in the disease’s later stages, significantly decreasing the probability of successful treatment. This is due largely to the fact that so little is known about ovarian cancer. It is my sincere hope that through further innovation and cross-institutional research practices, we can better understand, treat, and ultimately beat this devastating disease that affects women across this Nation.”
Representative Rose DeLauro (D-CT) was also a champion for ovarian cancer funding this year. “As a survivor of ovarian cancer, I know how vital funding for cancer research is. I was lucky, and had excellent doctors who found the cancer by chance. I underwent treatment and I am fortunate to say that for 25 years now, I have been cancer-free—but I know that had my doctors not caught my cancer at the earliest state, the final outcome might have been very different. No one should have to rely on luck to survive. Research is a critical component in the fight against this disease, and I was very pleased that we were able to preserve funding for ovarian cancer research and Johanna’s Law implementation in the appropriations legislation passed by the House of Representatives.”