There is a practice in the Senate, primarily of corporate lobbyists, to hire low-income folks, usually minorities, to hold their place in line before Supreme Court or congressional hearings. There are firms that actually hire the standees, and contract with lobbying firms or corporations. Depending on the interest in the issue, standees can wait for hours before a hearing starts. Last time I checked with one of them, a standee told me he earned $10 an hour.
Nonprofits don’t have those resources, so we get there early and hope for the best. When we arrive, we face, usually in a line well in front of us, of weary looking people in jeans and tee shirts, holding up the signs of the individuals who will rush in with their $1,000 suits and shined shoes at the last minute and displace the standees.
Of all the abuses of corporate power in Washington, hiring line standers isn’t on the top of the list. But its symbolism is inescapable. The poor and disenfranchised literally give up their place to the wealthy and powerful.
Making compounded drugs safer
On May 9, the line standers were patiently waiting for the beginning of a Senate hearing on compounding pharmacies. It was too bad they wouldn’t be actually attending it. Like nearly all Americans, they will be affected by the decisions Congress makes about how these companies are regulated. Unlike a neighborhood pharmacy, where pharmacists prepare medications based on individual prescriptions for patients with special needs, compounding pharmacies now often serve hospitals or nursing homes and produce products in high volume, sometimes without individual prescriptions, and distribute their products across the country.
Late last year, a compounding pharmacy, New England Compounding Center, was responsible for an outbreak of bacterial meningitis that to date has killed more than 50 people and sickened more than 700. NECC was able to sell tainted injectable painkillers due to lax oversight by both Massachusetts regulators and the Food and Drug Administration.
The May 9 hearing addressed a legislative proposal to make compounding pharmacies safer. The decisions Congress makes on that proposal will affect anyone who ever gets surgery or an injectable painkiller. And yet the public, just like these line standers, generally doesn’t have a place at democracy’s table when these decisions are being made.
Bringing science into the debate
Neither, by and large, has science. Decisions about how best to regulate pharmacies that sell thousands of products to hospitals should be based on science. The evidence demonstrates that state boards of pharmacy lack the staff, and sometimes the authority, to do a good job policing these high-volume, high-risk operations. The FDA needs clear authority to regulate large compounding pharmacies to ensure the public health and safety.
We at the Union of Concerned Scientists are working with a coalition of public health, patient and consumer groups to strengthen the Senate proposal. The draft bipartisan bill would give the FDA power to oversee some, but not all, of these high-volume compounding manufacturers. The FDA wouldn’t regulate compounding pharmacies that made non-sterile products, even powerful high-risk medications, and it wouldn’t oversee compounding pharmacies that shipped all their products within one state.
Our coalition is pushing for FDA authority over all compounding pharmacies that make large volumes of products without specific individual prescriptions, regardless of the type of product or whether it is shipped in-state or across state lines. We also want Congress to give the FDA access to any pharmacy’s records, if the agency has received a complaint about the pharmacy, or has other evidence that suggests the pharmacy is breaking the law. Without the right to access records, the agency has to go to court to get that access, an exercise that can delay agency action, and place patients in jeopardy.
Pushing back against disinformation
And yet special interests, in this case pharmacy trade groups, appear to be doing all they can to weaken legislative proposals pending in the House and Senate.
Indeed, Senator Pat Roberts (KS) was so angered by what he termed a special-interest disinformation campaign that he refuted all the “myths” about the Senate’s proposal, inaccurate information that was stirring up fears among local Mom and Pop pharmacy operations who believed that they would be subject to intense FDA scrutiny.
But here’s the good news for both science and democracy. It doesn’t take a huge amount of engagement to make your views known to your Senator and have them count. This debate is being influenced by 2,000 emails from pharmacy interests. But 2,000 emails to the eight key Senators negotiating this proposal aren’t very many.
If you are interested in the compounding issue, you can start to learn about it through the links in this blog, and an earlier blog, Compounding the Problem. You can let your Senator know that you are concerned about the safety of the drugs you may receive, and that you want Congress to pass strong legislation that ensures that all these high-volume pharmacies receive effective oversight and that the FDA has access to the records of any pharmacies that the agency suspects are breaking the law or harming the public without having to convince a court that the records are necessary.
People pick and choose what issues matter most. What is crucial is that in a democracy, we don’t give up our place. Our engagement can and does matter.