January 2020 - Medical Association of the State of Alabama

New Maternal Mortality Statistics Highlight the Need for Alabama to Take Action

Posted by Christina Flack on January 31, 2020

Largely due to the slow implementation of a standardized death certificate by states, data on maternal deaths has not been reported on the National Vital Statistics System since 2007. Meaning that, for over a decade, the United States has not recorded an official count of pregnancy-related fatalities, nor an official maternal mortality rate.

This year, however, we finally got a look at the numbers and, to the surprise of no one, they aren’t good.

The biggest takeaway is that the way we record deaths still isn’t very reliable and, for the second time in less than twenty years, the government is reformatting the death certificate.

Still, the government’s findings (separated by three separate formulas and spanning over sixty pages) help to shed light on the current maternal mortality crisis. Whatever statistical issues there might be, the data conclusively shows that the rate of pregnancy-related deaths has increased substantially over the past decade.

In total, 658 women were identified as having died from pregnancy-related causes (during pregnancy, at birth, or within 42 days after birth) in 2018 – resulting in a maternal mortality rate of 17.4 deaths per 100,000 live births. These numbers place the U.S. in dead last among similar, developed countries.

Even more appalling are the stark disparities in maternal deaths of black women. Specifically, the maternal mortality rate for black women (37.1 deaths per 100,000 live births) was 2.5 times that of white women (14.7 deaths per 100,000 live births) and 3.1 times that of Hispanic women (11.8 deaths per 100,000 live births).

Significant disparities also exist among different age groups, with the maternal mortality rate of women 40 and older nearly 8 times (81.9 deaths per 100,000 live births) that of women under 25 (10.6 deaths per 100,000 live births).

Unfortunately, the numbers for Alabama are much worse. In fact, with 36.4 deaths per 100,000 live births, Alabama’s maternal mortality rate is more than double that of the national average. And since the state figures are merely a top-line summary, there’s no telling what the numbers are if you were to separate by race and age.

In our state, “becoming a mother can turn into a life-or-death situation,” said Dr. Grace Thomas, assistant state health officer for family services at the Alabama Department of Public Health. “It’s a failure of our healthcare system when that happens. We’ve got to do better.”

The good news? Alabama is working to do better.

Just last year, a coalition of Alabama doctors, nurses, public health leaders and others began forming a Maternal Mortality Review Committee (MMRC) under the umbrella of the Alabama Department of Public Health (ADPH) to get a deeper look at why mothers are dying and what we can do about it.

But volunteers can only do so much, and the MMRC lacks the funding for staff and supplies in order to properly review each death. We’re trying to change that.

Right now, the Medical Association of the State of Alabama – along with other stakeholders like March of Dimes, the American College of Obstetricians and Gynecologists, the American Academy of Pediatrics, and Johnson and Johnson – is spearheading an advocacy effort to bring attention to the issue of maternal mortality and see to it that the legislature provides ADPH with the resources it needs for the MMRC to be successful.

Dr. John Meigs, President of the Medical Association of Alabama, believes the MMRC, if properly funded, can reduce maternal mortality in a way similar to that of the initiatives ADPH has had in place on infant mortality – Alabama’s infant mortality rate was the lowest ever recorded in 2019.

“Ultimately, until we have a thorough review of the maternal death data, we can’t answer the all- important question of ‘why?’ when a mother dies and take steps to stop maternal death,” said Dr. Meigs. “But Alabama currently doesn’t fund maternal mortality review, and until we appropriately do so we can’t expect to be able to make informed health policy decisions as a state to move forward in eradicating maternal deaths.”

In other states, a funded MMRC has helped decrease the maternal mortality rate by over fifty percent. For only $478,000 (the amount ADPH requested for the MMRC in its budget), Alabama might be able to do the same.

Find out more about Alabama’s maternal mortality crisis and how you can join our campaign to Save Alabama Moms at alabamamedicine.org/savealmoms

Tags: maternal mortality, mmrc, savealmoms

Posted in: Advocacy

Proposed Importation of Prescription Drugs from Canada

Posted by Mallory Camerio on January 17, 2020

On December 18, 2019, the Food and Drug Administration (“FDA”) issued a proposed rule (the “Proposed Rule”) to amend its regulations to implement a provision of the Federal Food, Drug, and Cosmetic Act to allow importation of certain prescription drugs from Canada. The purpose of the Proposed Rule is to lower prices and reduce out-of-pocket costs for American patients. If the Proposed Rule is finalized as proposed, States or certain other non-federal governmental entities and their co-sponsors, if any (collectively “Sponsors”), would be able to submit drug importation program proposals (each a “Drug Importation Proposal”) to the FDA for review and authorization. If a Drug Importation Proposal were approved, it would be authorized for a 2-year period, with the possibility of extensions for additional 2-year periods.

The Proposed Rule would require each Drug Importation Proposal to:

Specify the eligible prescription drug the Sponsor seeks to import;
Demonstrate that the proposed importation program will pose no additional risk to the public’s health and safety;
Provide an explanation as to why the Sponsor expects the importation program would result in a significant reduction in the cost of such prescription drug to the American consumer; and
Identify the foreign seller in Canada that would purchase the drug directly from its manufacturer and the importer in the United States that would buy the drug directly from the foreign seller. The foreign seller must be registered with the FDA as a foreign seller and be licensed by Health Canada as a wholesaler, and the importer must be a State or FDA licensed wholesale drug distributor or State-licensed pharmacist.

At least one State, tribal, or territorial governmental entity would be required as a Sponsor of a Drug Importation Proposal to offer enhanced accountability and to protect the public health. Co-sponsorship is included in the Proposed Rule to allow the State, tribal, or territorial governmental entity to benefit from the experience of pharmacists and wholesalers.

To be eligible to be imported, a prescription drug would need to be approved by the Health Products and Food Branch of Health Canada and, but for the fact that it deviates from U.S. labeling, also meet the conditions in an FDA-approved new drug application or abbreviated new drug application. Essentially, eligible prescription drugs are those that could be sold legally on either the Canadian market or the American market with appropriate labeling. An eligible prescription drug would need to be relabeled with the required U.S. labeling, prescribing information, and patient information before sold in the United States. Also, to be eligible for importation, the prescription drug must be currently marketed in the United States (which would allow the FDA to be better able to determine if there is a safety issue with an imported drug). Several categories of prescription drugs are excluded from the Proposed Rule including controlled substances, biological products, infused drugs, intravenously injected drugs, and drugs that are inhaled during surgery.

The FDA is seeking comments on the Proposed Rule until March 9, 2020. Stay tuned for updates as to whether or not the Proposed Rule is revised or finalized as proposed.

Anthony Romano practices with Burr & Forman LLP in the firm’s Health Care Industry Group. Anthony may be reached at aromano@burr.com.

Posted in: Uncategorized