Who’d have thought that Pat Roberts, a steadfastly conservative Kansas senator with a spotless anti-abortion voting record, would get mugged from the right?
But a new coalition of conservative and anti-abortion organizations formed recently to oppose a bill Roberts vigorously supports. The bill would strengthen federal oversight of large compounding pharmacies that ship sterile medications, such as injections, across state lines.
In a letter released July 9, the coalition decried Roberts’ bill as “the most anti-life bill headed for passage since 2010.”
The coalition questioned whether, under the bill, expectant mothers would continue to have access to a widely compounded drug that helps prevent premature births.
“Some women have abortions when told that premature birth is likely, especially when they lack access to affordable medication to safeguard the pregnancy,” the letter contends.
Compounding is a traditional part of pharmacy practice in which pharmacists create customized medications from scratch, but without having to meet the same safety and quality standards that large drug manufacturers must follow.
A sharply worded reply issued by Roberts’ office this week contended that leaders of the new anti-abortion coalition have shown no interest in discussing what could be done to address their concerns or improve the legislation.
The statement suggested the anti-abortion members of the group may have been co-opted by compounding interests in Texas, where industry groups wield deep political influence.
“If this group was truly focused on the need to protect life, they would contribute to our efforts to end this series of tragic deaths and hundreds of instances of critical illness due to flagrant disregard of federal and state oversight by bad manufacturers working under the guise of compounding pharmacy,” Roberts’ statement read.
A meningitis outbreak caused by contaminated steroid injections last fall sickened more than 700 patients and killed 61. The outbreak, linked to a large compounder in Massachusetts, allowed Roberts and other senators who have long worked on the issue to find political support in Congress for tighter regulations.
Should Roberts’ bill become law, it would signal the first time federal legislators have strengthened compounding regulations since Kansas City pharmacist Robert Courtney pleaded guilty a decade ago, admitting that he had diluted thousands of doses of chemotherapy medication.
Roberts hopes that the Senate will act on the bill before its August recess. The U.S. House is considering two similar measures.
The Kansas City Star first exposed concerns about the safety of compounded drugs in a 2002 series.
The coalition opposing the bill was organized by the Association of American Physicians and Surgeons, a conservative group whose most prominent member is U.S. Sen. Rand Paul, a Kentucky Republican and an ophthalmologist.
Jane M. Orient, a physician and the association’s executive director, said in an interview this week that no amount of tinkering with the bill would satisfy her coalition because it would permit the expansion of Food and Drug Administration authority over pharmacy compounding.
The FDA, she said, has grown too close to the large pharmaceutical manufacturers it regulates and has squelched competition.
“I don’t see any reason to support the legislation,” Orient said. “The FDA has been abusive. It does not deserve to have its authority expanded.”
The letter announcing opposition to the Senate bill is signed by 23 other physicians and the leaders of several anti-abortion and conservative political groups, including Phyllis Schlafly, founder of the Eagle Forum, and Steven F. Hotze, a conservative Texas physician who argues against federal regulation of compounding.
The coalition also is concerned that the Senate bill could allow the FDA to write regulations restricting the application of therapies arising from adult stem cell research.
But even other social conservatives don’t see that problem. David Prentice, a biochemist and senior fellow for life sciences at the Family Research Council, said Roberts’ bill would not give the FDA the authority that the coalition fears.
“I don’t think the bill affects adult stem cell therapies,” Prentice said. “Their concern was misplaced.”
The coalition’s entry into the compounding debate marks the first time organized anti-abortion interests have taken sides in a three-year dispute among the FDA, compounders and a pharmaceutical manufacturer over the drug hydroxyprogesterone caproate.
Since 2011, compounders have contended that their versions of the drug are far cheaper than the manufacturer’s FDA-approved product, Makena, and are a better option for pregnant women.
The drugmaker K-V Pharmaceutical Co., of St. Louis, offered steep discounts off its list price of more than $1,000 per dose, but it later sued the FDA, alleging the agency had done little to prevent unapproved versions of its products from being marketed.
K-V Pharmaceutical recently joined a working group headed by former Health and Human Services Secretary Tommy Thompson that supports the Senate compounding bill.
To reach Mark Morris, call 816-234-4310 or send email to mmorris@kcstar.com.
No comments:
Post a Comment