Lobbyists roll up sleeves for compounding battle
OCTOBER 15, 2013
Lobbyists roll up sleeves for compounding battle
By ANDREA DRUSCH | 9/24/13 5:02 AM EDT
If you want to know how nervous the pharmaceutical industry is about the prospect of new federal regulation of compounding pharmacies — like the one involved in last year’s lethal fungal meningitis outbreak — look to K Street.
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?
Read more: http://www.politico.com/story/2013/09/lobbyists-roll-up-sleeves-for-compounding-battle-97221.html#ixzz2hphpNqMn
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