Carly Fiorina, in the second Republican debate, said this:
if you want to stump a Democrat, ask them to name a accomplishment of Mrs. Clinton's.
Unfortunately, that sort of rhetoric is not limited to the circus stage. We see the same thing quite often here on Daily Kos. In the first "Accomplishments" diary, I linked to some older dKos comments, because I didn't want this to turn into a pissing match. But it happens. It happens right here and right now. Here are a couple. I'll leave the names off, but you can follow the links if you want to:
Oh. I thought you meant the victims of her... (1+ / 0-)
...
She has a record of virtually zero accomplishment other than being placed in high positions. I would have hoped that Dems who despise the loss of blood and treasure resulting from the morons who gave Bush permission to wage war at will would refuse to support those morons....but it seems to not be true.
by XXXXXX on Sat Sep 12, 2015 at 02:13:53 PM EDT
XXXXX, you know Hillary's not a Dem, don't you? (1+ / 0-)
...
Now let's hear about some of Clinton's "strengths" and "accomplishments" please, if you can.
by XXXXX on Tue Sep 15, 2015 at 09:07:15 AM EDT
Okay, it's happening. So let's look at another Clinton accomplishment, okay?
The first diary in this series was Hillary's Accomplishments - 2012 Ceasefire.
For the second one, we're going to look at a piece of legislation while she was in the Senate.
In 2002, Senator Clinton sponsored S.2394 - A bill to amend the Federal Food, Drug, and Cosmetic Act to require labeling containing information applicable to pediatric patients. The Act
Amends the Federal Food, Drug, and Cosmetic Act to require license applications for new drugs and biological products to assess such drug's or product's safety and effectiveness for relevant pediatric subpopulations, including dosage.
The Act passed out of committee but did not become law. That became critical when, in October, 2002, a federal court struck down the 1998 FDA Pediatric Rule, saying the FDA lacked authority to write such a rule.
But a year later, Senator Clinton and Senator Mike DeWine (R-OH) introduced the Pediatric Research Equity Act. That Act
Amends the Federal Food, Drug, and Cosmetic Act to require license applications for new drugs and biological products to assess such drug's or product's safety and effectiveness for relevant pediatric subpopulations, including dosage.
That Act became law. And it became law, not just with the co-sponsorship of Senator Clinton, but with her active participation. In fact, it became law.
These are the remarks Senator Clinton made upon the passage of the Act through the Senate:
Mrs. CLINTON. Mr. President, I rise to mark the passage on the Senate floor of a bill, S. 650, that will assure the safety and efficacy of medicines for children, and address a problem that pediatricians, parents, and children's advocates have worked on for decades. A great deal of work went into this bill. So many hardworking, dedicated Senators made the effort on a bipartisan basis to come together around this important issue. In particular I want to thank Senators DEWINE, DODD, GREGG, and KENNEDY. Senators DEWINE and DODD and I now have worked on pediatric research for many years, and we will continue to be around to work on behalf of children, who, without dedicated advocates like Senators DEWINE and DODD, would not have a political voice.
Last year this bill was passed out of committee but held up on the floor toward the end of session. Unfortunately, that meant no backstop was in place to assure the continuation of a minimum baseline protection for children when last October, a District Court judge struck down the 1998 FDA Pediatric Rule, based on his view that Congress did not intend to charge FDA with making sure our children are protected. Today, we pass legislation to clarify that FDA authority to assure safe, effective medicines for children is exactly what we intend.
This bill was the product of compromise. We all worked hard and made concessions on all sides to craft the language the Senate was able to pass today. Some of us would have preferred a strong, permanent assurance for children, and not a sunset of these crucial protections in 2007. Indeed, because the purpose of this legislation was to address the uncertainty caused by the court-triggered lapse of pediatric studies, not codify such a lapse into statute, I cannot support the sunset provision.
But others may have wished to change other aspects of the bill. So we were able to give on each side for the sake of moving forward on a central accomplishment providing FDA with undisputed, unencumbered authority to require and enforce studies of whether medicines important for children are also safe and effective for children.
Our managers' amendment and the colloquy we submitted today reinforce that as the goal we all share here today in passing this language.
I want to take a moment to bring special attention to the amount of work and cooperation that the chair and ranking member of Senate Health Education, Labor, and Pensions Committee have dedicated to this bill, both last Congress and this Congress. Senator Gregg and Senator Kennedy, and both their staffs, Vince Ventimiglia, and David Dorsey have lent their expertise and their time to this issue. Senator DEWINE's staff, Abby Kral, and Senator Dodd's staff, Ben Berwick this year, Debra Barrett last year, have been more dedicated than anyone on this issue.
I particularly want to acknowledge the outside experts who have devoted so much time to advocating on behalf of children and making this proposal a reality. The American Academy of Pediatricians, Elaine Vining here in DC and all the pediatricians across the country, have been championing this issue for so long. Also, Mark Isaac and Jeanne Ireland at the Elizabeth Glaser Pediatric AIDS Foundation have been tireless in their efforts. The children's hospitals, and so many others cannot be thanked enough. We would not be here today without their passionate advocacy. I also appreciate working with Phrma to get to this point and hope to continue to work with them in order to move this bill quickly into law.
(This is a strong testament to Hillary Clinton's ability to work in a bipartisan manner to pass important legislation.)
In 2007, Senator Clinton led the effort to renew the Act as part of the Food and Drug Administration Amendments Act of 2007 (FDAAA). This was signed into law in September, 2007.
PREA applies to any application for a new ingredient, new indication, new dosage form, new dosage regimen, or new route of administration. [1] It applies in two situations. First, for pharmaceutical products used for a substantial number of pediatric patients for the labeled indications, where the absence of adequate labeling could pose significant risks to pediatric patients; and second, there is reason to believe that the product would provide a meaningful therapeutic benefit over existing therapies for pediatric patients for at least one of the claimed indications and the absence of adequate labeling would pose significant risks to pediatric patients.[2]
Here are just a few examples of changes that have come about because of PREA and its companion Best Pharmaceuticals for Children Act:
Fluoxetine (Prozac) underwent major labeling changes after a 19-week clinical pediatric trial of its use for major depressive disorder in patients aged 8 to 17 and obsessive-compulsive disorder in patients aged 7 to 17 found that those taking the drug experienced more limited growth than those not taking it. The label now warns physicians to monitor the height and weight of pediatric patients treated with fluoxetine.
Gabapentin (Neurontin), a drug used for seizures in children, underwent labeling changes after pediatric studies demonstrated that higher doses were required to control seizures in those younger than age 5 (on a per-kilogram basis, patients younger than 5 years appear to clear the drug more quickly than adult patients and therefore require higher doses for the drug to be effective). In addition, new adverse events (for example, aggression and hostility) were identified in children younger than age 12.
Labeling changes were made to betamethasone, a corticosteroid used in several common, over-the-counter topical creams for jock itch \ or athlete’s foot (Lotrisone, Diprolene, Diprosone), after studies showed hypopituitary–adrenal axis suppression in children under age 12. The label now indicates that the creams should not be used in this age group.
Etodolac (Lodine), used for symptom relief in juvenile rheumatoid arthritis, underwent labeling changes after studies showed that patients aged 6 to 16 years required a higher dose (on a per-kilogram basis) than expected—approximately twice the lower dose recommended for effective treatment in adults.
Labeling changes were made to fluvoxamine (Luvox), a treatment for obsessive-compulsive disorder, to recommend higher doses in adolescents than were previously indicated, with the exception of girls aged 8 to 11, who may require lower doses because the drug can make them drowsy.
These Acts have also revealed important information about adverse drug events. Adverse events have been reported for 54 drugs. These reports include suicidal ideation in patients taking selective serotonin reuptake inhibitors (SSRIs) and ribavirin (Rebetol)–interferon alfa-2b, recombinant (Intron A), as well as suppression of linear growth in children taking fluoxetine (Prozac) and systemic corticosteroids. In addition, accidental exposures to and misuse or abuse of the fentanyl transdermal system (Duragesic) have been revealed: between 1990 and 2003, four pediatric deaths were reported; during the year of mandatory reporting, five pediatric deaths were reported.