Would you rather take a $1,500 mass-marketed drug with toxic ingredients to prevent premature childbirth, or a ten-dollar compounded nontoxic version? You may not have a choice. Two Action Alerts!

As we reported last year, KV Pharmaceutical manufactures Makena, a $30,000-per-pregnancy synthetic form of progesterone prescribed for women with high-risk pregnancies to help prevent pre-term births. Compounding pharmacies have been making a safer and far less expensive version of the medicine for over a decade. Now KV has filed a complaint with the International Trade Commission (ITC) in an attempt to stop the supply of the ingredients for the compounded version. Since the entire supply of its active ingredient is imported, this move would effectively keep compounding pharmacies from making and selling this important medicine—and would completely eliminate the competition.

One of the biggest factors is cost—the compounded version costs only $200 per pregnancy, less than one percent of the price that Makena is now selling for. Who knows what Makena will cost if it gets the monopoly it wants? Eliminating the compounded version would make the drug cost prohibitive for many, many women, and some of the available supply of the drug would be eliminated, which could cause a mother to lose her child.

On top of that, sensitive women simply can’t take the commercial drug because it contains the toxic preservative benzyl alcohol, which has been linked to “gasping syndrome” in infants and, according to the CDC, has caused six neonatal deaths. Doctors can prescribe a compounded version of 17P without the benzyl alcohol, but if the ingredients are banned to compounders, only the version with the benzyl alcohol is left.

As you may remember, two years ago, KV Pharmaceutical received “orphan drug” status for 17P, the successful progesterone-based drug, and immediately tried to ban the sale and production of the compounded version of 17P in an attempt to secure a monopoly. This caused an outpouring of grassroots protest, prompting FDA to officially state that compounding pharmacies could continue to provide 17P.

In KV Pharmaceutical’s new attempt to eliminate compounded 17P, they’ve filed a section 337 case with the ITC asking that the active pharmaceutical ingredient, called API, be banned from import, creating a monopoly for the amount KV produces! The company is actually claiming that KV is the entire domestic industry for 17P, and that imports of 17P for use by compounding pharmacies will thus destroy the domestic industry.

Just think about that for a second. “We are the only domestic industry for the ingredient”—meaning, in effect, that there is no domestic competition—“so other companies shouldn’t be allowed to receive the ingredients because it’s a threat to the industry”? Seriously? They’re not competition for you, but their competition hurts you?

In addition, they are shamelessly trying to eliminate competition using Makena’s orphan drug status to support its actions, when the whole entire point of orphan drugs is to provide incentives to manufacture drugs because there is a shortage!

In their complaint, KV accuses compounding pharmacies of having an “unlawful drug manufacturing and distribution enterprise…which proceeds under the fiction of individualized drug ‘compounding.’ ” They are essentially claiming there is no difference between compounding and drug manufacturing—an underhanded attempt to remove from the market compounded drugs that are exempt from the FDA drug approval process. Even worse, KV is riding the wave of the political backlash against compounding pharmacies due to the recent meningitis outbreak we reported on last month, and specifically mentions that tragic case as a major justification for its claim.

Needless to say, if the ITC rules in favor of KV, it would set a terrible precedent for active pharmaceutical ingredients imported for other compounded drugs.

The very latest twist in this is that KV Pharmaceutical has filed for bankruptcy protection and is, according to our sources, asking for compensation from compounding pharmacies—based on the inflated price of Makena, not of the compounded 17P—which compounding pharmacies can ill afford. If KV wins their ITC suit banning the supply of API for 17P, then actually goes bankrupt, the drug could be lost to women forever. It is unlikely other pharmaceutical companies will try to spend the money to manufacture the drug, given its history.

Compounding pharmacies are already regulated through state pharmacy boards. But now, after the meningitis debacle, Sen. Ed Markey (D-MA)—despite his statements to those involved that he would hold off and work with others—has introduced legislation to give FDA greater enforcement powers over compounders, usurping state authority.

Sen. Markey’s bill, HR 6584, would empower FDA to create a list of drugs that cannot be compounded. Who would set the standard? It would be at the FDA’s own discretion—which means that anything can be on the do-not-compound list.

Furthermore, one of the ways the FDA can consider whether to include something on the list is if the drug is “reasonably likely to cause an adverse effect on safety and effectiveness.” Of course, FDA’s standard of safety and effectiveness is usually code for “double blind random-controlled studies”—which compounded drugs are specifically exempt from. Therefore any compounded drug could be deemed unsafe and ineffective and might therefore appear on the list—especially considering how strongly FDA is influenced by pharmaceutical interests.

More to the point, it’s an inapplicable standard: compounded drugs are by definition medicine that is individualized for the needs of the patient. How can you run a drug trial on one person? Not only that, but compounded drugs are substantially similar to approved drugs or already have a USP monograph, so safety is demonstrably not an issue.

The bill limits compounding to a per-patient prescription basis. This could completely eliminate “office use”—that is, when a practitioner administers a medicinal preparation directly to a patient, in his or her office or other treatment area, for the immediate treatment of a problem. In these instances a doctor would need to have a reserve supply on hand without a prescription. And pharmacies might need to start production on various compounded formulations in advance of a prescription—especially if they know they have a standing order on certain formulations.

The registration and inspection exemptions for compounders would be eliminated if the FDA determines that a compounding pharmacy is in “in effect manufacturing.” What does that phrase actually mean? This, too, is for the FDA to decide. And it needs watching, since the FDA may try to use it as a club against compounding.

We are working with key members of the Senate to ensure that any new legislation is not used as a back-door mechanism by Big Pharma to eliminate compounding pharmacies, which would secure a monopoly for commercial drugs.

The Alliance for Natural Health USA
1350 Connecticut Ave NW, 5th Floor, Washington, DC 20036
Ph: 800.230.2762
www.anh-usa.org