Feature Article: October 2019 – Group Starts Grassroots Campaign to Educate Practitioners and Patients on FDA Actions Regarding BioIdentical Hormones

Group Starts Grassroots Campaign to Educate Practitioners and Patients on FDA Actions Regarding BioIdentical Hormones

Jeff Morris

Compounding pharmacies are a critical component of the treatment options available to age management medicine practitioners. The FDA is currently considering policies that would, at minimum, make it harder to get prescriptions filled for bioidentical hormones, and at worst, outlaw compounded hormones. The policies would almost certainly put many compounding pharmacies out of business.

Gina Besteman, Director of Compounding and Dispensing at Women’s International Pharmacy in Madison, WI, says compounding pharmacy is a critical part of the healthcare delivery system. “Even though it is literally the foundation of modern medicine, it is often misunderstood in a world dominated by mass manufacturers of prescription drugs,” she said—and such misunderstandings can lead to legislative and regulatory overreach. That is precisely what is happening now.

“At the beginning of 2019, then-FDA Commissioner Scott Gottlieb came out with the Compounding Priorities for 2019, and one of these was to finally finalize the MOU,” Besteman explained. The MOU, or Memorandum of Understanding, is an agreement that was authorized by Congress in 1997 under section 503A of the Food, Drug and Cosmetic Act, but has never been finalized. The MOU needs to be signed by each individual state. The purpose of the MOU is to help states and the FDA address any legitimate issues with compounded medications that are shipped into one state from a pharmacy in another state. The intent of this law is to make sure that states share information among themselves and with the FDA to help it address legitimate consumer complaints and potential safety issues.

“The main issue,” says Besteman, “is the FDA has changed its definitions of distributing and dispensing, and combined them into one thing, when in other legal definitions they have always been two completely different things.”

Distribution vs. Dispensing

According to Besteman, distribution would be a pharmacy sending something to a practitioner’s office that does not have a patient’s name on it. Dispensing would be something intended for a specific patient. “They are confusing two very different items,” she says, and by so doing, exceeding the intent of the original congressional mandate. And under the terms of the proposal, pharmacies located in states that do not sign on would be limited in shipping compounded medications out-of-state to no more than 5 percent of the total medications they distribute or dispense. Even if they do sign the MOU,  special scrutiny would be given to pharmacies that fill more than 50 percent of prescriptions to out of state patients. It is unclear what this scrutiny would entail. But if a 5 percent limit is imposed, many pharmacies that specialize in compounded medications would go out of business.

To combat this overreach and attempt to block the threat to compounding pharmacies, Besteman is advocating for practitioners and patients to take action through SaveMyCompounds.com, a grassroots advocacy organization that hopes to make an impact—and soon. “At this point they said they would finalize it this year, and there’s not much time left in this year,” she says. “We just got started, and already have over 20,000 signatures. We’re working with other compounding pharmacies across the country, and trying to get people to contact their congresspeople. We’re hoping they will eliminate the percentage restriction.”

SaveMyCompounds maintains that under state and federal law and years of legal precedent, distribution does not include patient-specific prescriptions, and the MOU was never intended to include or limit regular prescriptions filled by compounding pharmacies and shipped across state lines. It notes that almost half the states have indicated that they will not sign the current draft MOU, which poses onerous regulatory burdens on individual state boards of pharmacy without a funding source. In fact, not a single state has indicated that it will sign FDA’s latest draft. Some are even prohibited by state law from entering into this type of agreement. Essentially, FDA wants state boards of pharmacies to enforce rules that have little to do with patient safety, and which would deplete the resources that states need for safety and quality control inspections.

According to SaveMyCompounds, in the intervening years since the MOU was first put on the books, state regulation of compounding pharmacy and interstate shipment has grown very robust. For example, all states now require an out-of-state pharmacy to be licensed or registered in the state where the prescription is actually sent. All states have adopted much more rigorous quality standards than were in existence in 1997 and have enacted other stringent requirements to insure patient safety and quality control. And states share information, which was the primary goal of the 1997 law and the MOU. If a resident of a state has a complaint on a medication filled by an out-of-state pharmacy, the resident files a complaint in their home state. The state can take enforcement action if there is a legitimate complaint, including revoking the out-of-state license of the pharmacy. So, in many ways, states stepped in to do the job envisioned in the 1997 law.

Also, says SaveMyCompounds, since 1997, many compounding pharmacies have specialized in the medications they provide. Some specialize in making medications for BHRT patients. Some have other specialties such as serving autistic children, individuals with auto immune disorders, organ transplant patients or pediatric care. They excel at their specialty, and medical providers in most if not all the states use and value their services. Some provide medications that are simply not available in each individual state.

Unfortunately, by not signing the MOU, states would be restricting their compounding pharmacies to the 5 percent limit, which would instantly put them out of business. The only solution is to convince the FDA to withdraw its current draft MOU and issue one that guarantees a patient’s access to compounded medications from his or her pharmacy of choice.

Challenge to BHRT

But there’s another problem facing compounding pharmacies, practitioners and patients as part of the FDA review. FDA has contracted with the National Academy of Science, Engineering and Medicine (NASEM) to determine whether women need the option of compounded bioidentical hormone replacement therapy (BHRT), or whether existing manufactured drugs made by the large drug companies can meet this need. NASEM has created an “ad hoc” committee that is conducting this study.

As another advocacy organization, Atlanta-based Alliance for Natural Health-USA, notes, “All of this is happening simultaneously to the FDA threatening to eliminate consumer access to compounded bioidentical hormones such as estriol and progesterone. These and other hormones have been nominated to the agency’s ‘Difficult to Compound List’; items that appear on the final list will not be able to be compounded at all…As we’ve said all along, it is our opinion that the objective in all of this is to shut down compounding because it threatens Big Pharma profits, and Big Pharma funds the FDA. We have to fight back and ensure that patients can get the medicines they need.”

NASEM’s own description of the study reads as follows:

An ad hoc committee of the National Academies of Sciences, Engineering, and Medicine (National Academies) will conduct a study to assess the clinical utility of treating patients with compounded BHRT drug products. The committee will:

  • Review the current and historic use of compounded BHRT drug products to treat patients, including information about the medical condition(s) that these compounded drug products have been used to treat;
    •Describe the physical and chemical characteristics of compounded BHRT drug products (e.g., active ingredient, inactive ingredient(s), dosage forms, routes of administration, strengths);
    • Review and assess the available evidence (or lack of evidence) regarding the safety and effectiveness of compounded BHRT drug products;
    • Based on the available evidence, summarize findings and make recommendations with respect to
    – the clinical utility of compounded BHRT drug products;
    – whether the available evidence of safety and effectiveness supports use of compounded BHRT drug products to treat patients; and
    – the patient populations that might need a compounded BHRT drug product in lieu of an FDA-approved drug product.

In other words, says SaveMyCompounds, FDA wants to decide whether women and men should even have the option of compounded BHRT. Besteman points out that the ad hoc NASEM committee is composed of medical professionals with sterling credentials. However, none have clinical expertise and extensive experience with treating patients with compounded hormones. The questions that many of the committee members have asked at meetings show an alarming lack of knowledge of the topic they are considering. And while NASEM is a well-respected organization, its committees are most familiar with the type of scientific and research information provided by drug companies that spend hundreds of millions of dollars for drug approvals. And since compounded bioidentical hormones cannot be patented as they have the same molecular structure as exists in the human body, this type of information and double-blind studies are simply not available.

SaveMyCompounds says, “All of this means that the NASEM committee will be naturally biased towards hormones marketed by the large drug companies, with a one-size approach that has failed women’s health. And if they determine that women don’t need compounded alternatives to drug-company hormones, it will be the basis for FDA moving to outlaw most if not all compounded BHRT.”

So, NASEM needs to hear from professionals with experience in the use of BHRT—and do so immediately. The urgency is clear in this message from NASEM:

  1. The cBHRT committee will host a public session on November 12, 2019.
    1. In an effort to ensure that the members of the cBHRT study committee have sufficiently reviewed the available evidence relevant to their charge, the committee will host a public meeting on the afternoon of November 12, 2019. At this meeting, the committee hopes to gather additional evidence-based data on the safety, effectiveness, and use of compounded BHRT products. To support this effort, the committee is seeking nominations for speakers who are clinicians who regularly prescribe cBHRT or pharmacists who extensively compound BHRT, and who are willing to share relevant data to inform the committee’s work. Please send all nominations to the study email: BHRT@nas.edu prior to Monday, October 14, 2019.  Please include contact information for the nominee, as well as a short biosketch or rationale with your submission. Given the rapidly approaching event, we would appreciate your understanding and adherence to this timeline.

Obviously it is too late to comply with the Oct. 14 nomination deadline, but it is not too late to submit comments ahead of or attend the public session.

Besteman urges everyone to take action at SaveMyCompounds.com.