As lawmakers have introduced bills in the House and Senate to regulate these drug-making practices, pharmacies, pharmaceutical companies and trade groups are ramping up their lobbying support for the battle to come.
In the past two months, at least 10 reports filed in the Senate’s lobbying database have named pharmacy compounding as an area of interest. Major players are signing on new help and shelling out big bucks to protect their interests in a policy debate that could seriously alter the way they do business.
Both the House and the Senate bills are proposing new Food and Drug Administration oversight of pharmacy compounding after 750 people were infected and more than 60 killed by contaminated steroid injections from a compounding center in Massachusetts a year ago.
Traditionally, licensed pharmacists have been allowed to mix or alter drugs according to a doctor’s prescription — because of an individual patient’s allergy or child’s dosage needs, for instance. That’s been overseen by state pharmacy boards, and no one wants to interfere with that.
But compounding has grown from a useful service provided by local pharmacies to large-scale production of medicine that doctors and hospitals administer but without the rigorous scrutiny FDA gives to pharmaceutical companies.
And what happened at the New England Compounding Center now has lawmakers calling for federal oversight — not of local pharmacies but of compounders that make big batches of medicine and ship them to providers.
On one side of the policy debate are the pharmaceutical companies, who want full FDA oversight of large-scale compounders, citing the gaps in oversight that could result in outbreaks like the one in Massachusetts. It’s a safety issue, they say, and compounders also shouldn’t be able to make and sell copies of FDA-approved products without having to meet FDA’s rigorous manufacturing standards.
On the other side are the compounding pharmacies and the large industry surrounding them. They’re warning that overregulation will prevent patients from getting the unique drugs they need.
Both sides are spending freely to have their voices heard on the Hill as the legislation moves forward.
The International Academy of Compounding Pharmacists, one of the biggest voices on the side of the compounding industry, has had lobbyists on staff since 2006, spending an average of about $20,000 per quarter. But early this year, after the Massachusetts outbreak, the group signed on two new firms to work on compounding regulations — and its lobbying expenditures have gone through the roof. It spent $277,840 in the first quarter of 2013 alone, and nearly $440,000 by the end of the first six months.
Meanwhile, pharmaceutical groups like Auxilium, KV Pharmaceutical and the Generic Pharmaceutical Association are also staffing up on lobbyists. They’re following a mix of issues but all have listed compounding as an area of interest. The GPhA has already spent more than $1 million this year and nearly $2 million in 2012.
What’s at stake for pharmacies that compound if the federal legislation were to give the FDA broad oversight of the industry?
Jim Smith, president of the Professional Compounding Centers of America, a for-profit company that provides compounding assistance to pharmacies, says it would be terrible for patients — because small pharmacies may throw in the towel on making some of the most-needed drugs.
In a recent survey, he said, 40 percent of his group’s members said they would stop doing certain types of compounding if the bills passed.
“Pharmacists don’t want to see the FDA engaged or involved with the regulation of pharmacies,” Smith said.
The two bills would limit the amount of compounded drugs a pharmacy can trade across state lines without being subject to FDA regulation.
The main difference is that the Senate bill, sponsored by Sen. Tom Harkin (D-Iowa), would give the most authority to the FDA — it would apply to all compounds traded across state lines. In the House version, by Rep. Morgan Griffith (R-Va.), FDA regulation would kick in only when compounding is a big portion of a pharmacy’s business — when more than 5 percent of its total output is compounds traded across state lines.
At stake for the pharmaceutical companies, who are lobbying for broader FDA oversight, is what they see as the integrity of the FDA approval process. Companies hiring up lobbyists to work on the issue say they feel strongly about possible safety risks involved with unregulated drugs.
“The current debate has increased awareness of some of the dangerous practices that compounding facilities like NECC have been conducting for years without appropriate federal oversight,” Auxilium Pharmaceuticals spokeswoman Nichol Ochsner said in a statement.
Audrey Wu, a spokeswoman for KV Pharmaceutical, warned that “the practice of traditional drug compounding has evolved to a large-scale industry of drug manufacturing without FDA evaluation for efficacy, safety and manufacturing quality.”
The example that comes up most often is the FDA’s decision in 2011 to allow the continued sale of a compounded version of Makena, a medication that reduces the risks of premature births. That drug was approved by the FDA, but the agency still allowed the compounders to sell the cheaper, copied version.
That incident has alarmed the pharmaceutical companies, and they’re worried that Congress won’t go far enough to stop compounders from making copy drugs without FDA approval. In a letter to the House bill’s sponsors, the GPhA and the Biotechnology Industry Organization warned that the current bill allows compounders to copy approved drugs, “thus potentially denigrating FDA’s established approval pathways as well as incentives for innovation.”
Also joining the fight to increase FDA oversight is a group of pharmaceutical and medical companies called the Working Group on Pharmaceutical Safety, whose members include Auxilium and KV Pharmaceutical. Its leadership includes former Health and Human Services Secretary Tommy Thompson, the chairman of TherapeuticsMD, and public health expert Sarah Sellers, an outspoken critic of compounding who has served as a member of FDA’s advisory committee on compounding.
The Working Group takes an even stronger stance against compounds, investing in lobbying efforts to prohibit compounds that copy commercial products. Spokesman Paul Lindsay said the group’s influence work has also included limiting patient exposure to “mass manufacturing under the guise of pharmacy compounding.”
“We’ve had productive meetings on the Hill and are encouraged by the work of the House and Senate towards a meaningful legislative agreement to provide appropriate oversight of pharmacy compounding,” Lindsey said.