As lawmakers consider bills to regulate the nation's compounding pharmacies, trade groups and pharmaceutical companies — including KV Pharmaceutical — are ramping up their spending on lobbyists in preparation for the battle ahead.
Bills have been introduced in both the House and Senate proposing that the FDA be given oversight of pharmacy compounding, and in the past two months, at least 10 reports have been filed in the Senate's database of lobbyists that name pharmacy compounding as an area of interest, Politico reports.
The International Academy of Compounding Pharmacists historically has spent an average of $20,000 per quarter on lobbying, but in the first six months of this year, it has spent $440,000 on lobbying, according to Politico. On the other side of the issue, pharmaceutical organizations such as KV, Auxilium and the Generic Pharmaceutical Association (GPhA) also are staffing up on lobbyists, with the GPhA spending more than $1 million already this year.
The pharmaceutical companies support giving the FDA oversight of the compounding pharmacies, saying it's a safety issue and arguing that compounders shouldn't be able to sell copies of FDA-approved drugs without having to meet the FDA's standards, according to Politico.
KV spokeswoman Audrey Wu said in a statement that drug compounding "has evolved to a large-scale industry of drug manufacturing without FDA evaluation for efficacy, safety and manufacturing quality."
KV, which just emerged from bankruptcy earlier this month, filed a lawsuit against the FDA last year for not cracking down on compounded versions of its premature birth drug Makena. The suit was later dismissed by a federal judge.
Makena is an injectable hormonal medicine that reduces the risk of early birth in women who have delivered a pre-term baby in the past. KV received approval to sell Makena in 2011, but pharmacies had already been compounding a similar, cheaper, drug for years for people with prescriptions.
Bridgeton-based KV, which is led by CEO Greg Divis, reported a net loss of $102 million in 2012 on revenue of $23 million.