Family questions proposed drug law

This fall Zac Foutz is a starting tight end for the Liberty University Flames, and he must be doing something right. Liberty upset Baylor University in its season opener.

But five years ago, when Foutz played for Cave Spring High School, he was sicker than he'd ever been in his life. He contracted fungal meningitis after an injection of contaminated steroids that were prepared by a compounding pharmacy outside Boston and sold to a clinic in Roanoke.

Foutz was one of at least 800 affected patients in 19 states, 76 of whom died.

The drugs were mass-manufactured in a mold-infested lab by the New England Compounding Center. Exploiting a loophole in federal regulations, and violating some others, the company marketed them to medical clinics across the country as inexpensive substitutes for brand-name pharmaceuticals.

The owner of the NECC is now serving a nine-year prison sentence, and NECC's supervisory pharmacist is currently on trial on murder and other charges. As a result of the scandal, Congress tightened a loophole regarding compounded medications in 2013, with passage of the Drug Quality Safety Act.

Currently, a patient with a doctor's prescription can obtain compounded medicines from a mom-and-pop compounding pharmacist. But if a medical office wants compounded drugs, it can obtain them only from compounding pharmacies known as "registered outsourcing facilities." Those must register with the U.S. Food and Drug Administration and adhere to regulated manufacturing practices.

Now, a new bill before Congress would alter that landscape. It's co-sponsored by Rep. Morgan Griffith, R-Salem. Its title is the "Preserving Patient Access to Compounded Medications Act of 2017."

Some lay persons and experts are raising alarm that if it passes, we'll one day have another scandal like NECC, and many more Zac Foutzes who suffer.

Compounded drugs make up a tiny sliver of the national market for medicine. Sometimes they're recommended when a patent who can't swallow a pill needs a medicine that's available only in pill form. In that case, a compounding pharmacist can turn it into a syrup. Or if a patient is allergic to an inactive filler ingredient in a particular pill, a compounding pharmacist can prepare it without the allergen. In both cases, that would happen only with a doctor's prescription.

Griffith's bill would allow mom-and-pop compounding pharmacists to sell quantities of drugs without a prescription to physicians, who could keep them on hand for when they're needed. Griffith told me that was Congress' intent with the Drug Quality Safety Act, but that the FDA is interpreting the law differently.

Although the same drugs may be available through the more heavily regulated registered outsourcing facilities, Griffith said, the outsourcing facilities often won't prepare small quantities of such medicines "because they can't make a profit on them."

"If you're in a big city, this is not really an issue, because you'll have a 24/7 compounding pharmacy that has someone on call," Griffith said.

But in a rural setting on a weekend, a compounding pharmacist isn't necessarily available.

As an example, he said an eye surgeon might need a compounded medicine to treat a football player who was injured on a Friday night. In rural towns on a weekend, that prescription could be unfillable. Griffith said that the bill is intended to allow doctors to stock only compounded medicines for which there is no name-brand pharmaceutical substitute, although "it doesn't say that now."

Griffith's bill would also allow pharmacies to sell more than 30 percent of their medicine across state lines. That's now barred by the FDA, and it's a problem in cities such as Bluefield and Bristol, which each fall in two states, Griffith said.

One group that has roundly praised the bill is the International Academy of Compounding Pharmacists. According to Federal Election Commission records, its political action committee has donated $10,000 to Griffith's campaign fund in the past two election cycles. Of that, they gave him $5,000 on June 27, 12 days after he introduced the current bill.

But Ben Foutz - Zac Foutz's father - is severely skeptical of the proposed law. If Griffith's bill passes, the NECC scandal is going to happen again, the elder Foutz said.

"Somebody will eventually exploit it for profit's sake and hurt people. It may not happen next year. It may not happen in five years. It probably will happen in our lifetime," said Foutz, who works in the medical device sales industry.

"A bad player in compounding is going to find a loophole to mass produce a drug in a way that's unethical and will harm somebody," he said.

One expert who agrees is Dr. Michael Carome, a 24-year veteran of the U.S.Public Health Service. He now serves as director of Public Citizen's Health Research Group. Public Citizen is a nonprofit consumer advocacy and lobbying organization in Washington, D.C.

If the bill passes, Carome said, any compounding pharmacist "could do what an outsourcing facility can do, but they're not subject" to the same FDA rules and regulations that the outsourcing facilities are.

"It would actually take us further back to where we were before the [Drug Quality Safety Act of 2013] was passed," Carome said. "It would completely undermine the law."

Griffith said that he's had exchanges with Ben Foutz on the subject, and that his staff is preparing replies to Foutz's most recent communications. He told me he invites input from Carome to help make the measure stronger.

Carome told me he believes Griffith has the issue exactly backwards, based on his quotes in a June 18 news clipping from the Richlands News-Press.

"It is my hope that this legislation will bring clarification as to what the FDA should be doing within their regulatory authority to ensure patient safety, while leaving the regulation of the traditional practice of pharmacy to the states, as it has always been," Griffith said in that article. "Specifically, this bill protects pharmacies engaged in office-use compounding."

The last sentence is the part Carome took great issue with.

"He's more interested in protecting pharmacies, as he said in his quote, than in patients' protection," Carome told me. "That's absurd."