Anti-Patient Bill Will Give FDA Even More Power

[barbara]

Ask your Senator to "Put a Hold"
on U.S. Senate Bill 959

Senate Bill 959 is the most anti-patient bill headed for passage since 2010. Sponsored by Sen. Harkin, it has passed out of the Senate HELP Committee and is headed for a vote on the Senate floor.

CLICK HERE http://www.senate.gov/general/contact_information/senators_cfm.cfmto find your Senator's contact information. Then ask your Senator to "put a hold" on S. 959, the so-called "Pharmaceutical Compounding Quality and Accountability Act."

S.959 vastly expands the power of the FDA, and will enable the FDA to shut down nearly all adult stem cell treatments. As many in the pro-life movement realize, the FDA already prohibits and prevents many adult stem cell treatments. The FDA obtained a ruling in federal court in D.C. against the use of adult stem cells by Regenerative Sciences. But FDA jurisdiction still has limits, which have enabled some breakthroughs with adult stem cells.

S.959 would vastly expanding FDA authority over nearly all biological products, except for "human blood and blood components for transfusion." (end of Section 2(b), p. 4 of S.959) Adult stem cells will not fit into this exemption, which means that the FDA will obtain jurisdiction to shut down adult stem cell treatments if this bill passes.

There is an additional anti-life consequence of this bad bill. A significant percentage of pregnancies are prone to premature birth, which often results in deaths of the unborn children or severe birth defects. A medication exists to help prevent these premature births: 17 alpha-hydroxyprogesterone ("17P"), which is a synthetic form of the female hormone progesterone. Compounding pharmacies currently provide this medication at an affordable cost to thousands of pregnant women who are prone to premature delivery.

But S.959 has a provision that prohibits compounding pharmacies from copying any FDA-approved medication. Only one drug manufacturer produces this (non-patented) drug, at an astronomical cost of $1500 per injection per week totaling $30,000 per pregnancy. Compounding pharmacies provide this same medication for $15-$20 per injection per week, totaling only $300-$400 per pregnancy.

S.959 eliminates competition by compounding pharmacies to big pharmaceutical manufacturers, and in this instance it will harm unborn children severely. Few will be able to afford the many thousands of dollars that the sole manufacturer of this medication charges.

S.959 is being railroaded through the U.S. Senate on the pretext that it addresses a meningitis outbreak that was caused by contaminated steroid injections made by New England Compounding Center late last year. Epitomizing the concept of "never let a crisis go to waste," enemies of life have exploited that crisis to insert harmful provisions into S.959.

If S.959 passes, then most adult stem cell treatments will cease, and pregnant women will lose affordable access to medication that prevents devastating premature births. Please distribute this email widely, and feel free to contact me with any questions or comments.

http://us1.campaign-archive2.com/?u=30a32513ae04f5445c95f3239&id=ff31164fbf

 

[Jeannine]

All these new rules and laws yet they can't even enforce the laws that exist. I think they should all go home and get a real job and leave us alone.

 

[barbara]

Amen to that. Talk about a lopsided, almost corrupt system. Check this out:

Law Weakens FDA Conflict-of-Interest Regs
By John Fauber, Reporter, Milwaukee Journal Sentinel/MedPage Today
Published: June 06, 2013

More drugs with dangerous side effects could get onto the market as the result of recent legislation that loosens conflicts of interest restrictions on experts serving on panels that advise the FDA, according to a new analysis.

The analysis, published in the journal Science, reviewed a 2007 law that placed caps on the number of waivers that could be granted allowing experts with conflicts of interest and a 2012 law that removed those safeguards.

"Panels top-heavy with experts who have financial ties to industry might be more likely to dismiss or ignore scientific evidence of risks or other problems," said lead author Susan Wood, an associate professor of health policy at George Washington University School of Public Health and Health Services.

Wood, a former FDA official, said removing the caps has been a high priority of the pharmaceutical industry.

Jenni Brewer, a spokesperson for the Pharmaceutical Research and Manufacturers of America, said the organization could not comment because it did not have time to review the Science paper.

The paper comes amid increased scrutiny of the FDA and its oversight and approval of the new drugs entering the market.

Generally, experts with financial conflicts are excluded from FDA advisory panels, but waivers can be granted if it is believed that their contribution won't affect the integrity of the process or the need for their services outweighs their conflict. Experts may not participate if their financial relationship exceeds $50,000.

The 2007 law that put caps on the number of waivers was passed because of concerns about the objectivity of FDA advisory panels.

Wood said that after the 2007 law went into effect the number of allowable waivers of conflicted experts dropped from 15% to 11.5% of advisory panel members in 2012.

The Science paper cited two cases where conflicts of interest may have played a role in the approval of drugs with significant safety concerns.

One advisory panel voted 15-11 that risk of blood clots from the birth control drug drospirenone (Yaz and Yasmin) was outweighed by the benefits. Four of those panel members had undisclosed conflicts of interest, which was enough to change the outcome.

In other case of advisory panel votes on the COX-2 inhibitors celecoxib (Celebrex), rofecoxib (Vioxx) and valdecoxib (Bextra), 93% of the votes cast by 10 members with conflicts of interest were in favor of the drugs. That compared with 56% of the 22 panel members who did not have conflicts.

Rofecoxib and valdecoxib were pulled from the market because of concerns about increased risk of heart attacks and strokes, and a black box warning was placed on celecoxib.

Stephanie Yao, a spokesperson for the FDA, said the agency uses advisory panels to provide independent, expert advice. She said stakeholders believe the pendulum has swung back and forth between conflict of interest laws being too strict to not strict enough.

Some panels require experts who may have financial relationships with drug companies, she said.

Through the second quarter of 2013, the FDA granted waivers for less than 1% of the 608 experts who have participated in meetings, she said.

She said the agency is committed to transparency and publishes all waivers on its website in advance of meetings.

The Science study questioned the need to remove the caps, noting that the number of waivers granted has only been a small percentage of what would be allowed, less than 1%, compared with an allowable number of between 11.5% and 13%.

"The caps never have come close to being breached," Wood said.

The paper also noted that contrary to claims that having caps would limit the number of new drugs, FDA approval of new drugs did not decline. In fiscal year 2011, the agency approved 30 new molecular entities -- a new class of drug -- compared with about the same number in 2002.

"Evidence we have identified does not support the need to remove the [conflict of interest] limitations," the authors wrote. "Removal of the caps weakens the system for managing COIs and creates the potential for an unlimited number of conflicted [advisory committee] members."