DTC -- Gone in 60 Seconds

04/23/2007 07:54 AM |

Lots of folks exercising their right to free speech over the issue of limiting free speech, aka: DTC advertising. The latest is the legislative attempt to give the FDA authority to ban advertising for the first two years after a drug is approved.

Here’s Senator Kennedy’s perspective:

"What we are looking at is the very rare circumstance. It would be used in the most limited kinds of circumstances, where the FDA … wants to give approval for a drug but is not sure and fears advertising will lead to massive use of the drugs.”

But FDA already negotiates such circumstances. That’s the key word, “negotiate.” And it’s not a finesse. Minus that word it’s … unconstitutional.

And there are many people, far less holy than Senator Kennedy, who see this as the first step towards banning pharmaceutical advertising altogether.

Consider what a Consumer Reports analyst said, "We don't know, and we won't know, how truly safe a drug is until it's been used in millions of people. The real testing of these drugs takes place after a pill hits the market, and that's why the advertising needs to be regulated."

Drugwonks does not believe that less information makes anything or anyone safter.

Make no mistake – this is a battle not only over the future role of the empowered health care consumer – but for the First Amendment.

Others are now saying, based on this new negative momentum, that DTC television ads will need to be more than one minute long to appropriately convey fair balance and adequate provision.

But it’s not a question of the time – it’s a question of the presentation. Can ads do a better job properly balancing risk and benefit? Most certainly. But it’s not necessarily a question of “more” as much as it is a question of “better.” And that means the FDA and industry (along with their advertising agencies) need better social science to determine how to best communicate such information to consumers.

Sounds like a good opening assignment for the agency’s new advisory committee on risk communications.

If we truly want to create a situation where our medicines are “safer” we must learn how to better communicate risk and benefit – not limit it.

Otherwise the empowered health care consumer might very well be gone in 60 seconds.  Read More & Comment...

Virginia Tech

04/20/2007 10:43 AM |

I agree with Bob Goldberg's recent post refering to the uses of anti-psychotics and how they might have helped control the Virginia Tech killer, if they were taken, a big IF.. I also believe that universities should be able to mandate ongoing psychiatric care for someone like this - "if you don't like it, then leave the university."
which is not the say that a treating psychiatrist would have been able to intervene in time. It is not for sure that the killer would have revealed his plan beforehand. But if he had, then the treating psychiatrist would have had an obligation to admit him for acute homicidal ideation. It is also obvious that a person like this, with such a known psych history, especially with violent ideation, should not be allowed to purchase guns, and certainly computers could be used to create such a useful databank that gun stores could adhere to.
There is another issue to address - one that I have written extensively about in my book False Alarm: the Truth About the Epidemic of Fear.
Namely that it is too easy to personalize what you see in the news, too easy to attach yourself voyeuristically to a crime like Columbine or this one and feel as if it is going to happen to you.
THis kind of fear is infectious, and the killer knew this, which was one of the reasons he may have chosed a Columbine-like model.
My friend Gary Baumgarten of Paltalk, formerly of CNN radio, has written about this fear factor today in his blog and cited my book.

http://www.paltalk.com/newstalk/msiegel_041907_archive.shtml#comments  Read More & Comment...

Does Stephanie Saul Oppose A Woman's Right To Choose?

04/20/2007 09:35 AM |

She writes about a new drug designed to reduce the number of times a woman menstruates as if this were something drug companies were trying to take away from women or make them ashamed of. Why can't women choose to take control of their bodies? And incredibly THIS gets front page coverage at the NYT but not the article about the benefits of antidepressants. In fact the NYT did not assign a staff reporter to that important story. Disgusting.


http://www.nytimes.com/2007/04/20/health/20period.html?_r=1&oref=slogin  Read More & Comment...

Krugman Calls Blacks and Latinos "Idiots"

04/20/2007 09:16 AM |

Why? Because they support Medicare advantage plans that give low income and chronically ill seniors more benefits at a cost with free drugs.... (Refer to Peter's post on Mark McClellan on how this happened..)

Krugman always writes like someone who finds it helpful to grind his axe on the necks of others. This piece is no different. Read all about it in his latest meltdown....

The Plot Against Medicare

"The plot against Social Security failed: President Bush's attempt to privatize the system crashed and burned when the public realized what he was up to. But the plot against Medicare is faring better: the stealth privatization embedded in the Medicare Modernization Act, which Congress literally passed in the dead of night back in 2003, is proceeding apace.

Worse yet, the forces behind privatization not only continue to have the G.O.P. in their pocket, but they have also been finding useful idiots within the newly powerful Democratic coalition. And it's not just politicians with an eye on campaign contributions. There's no nice way to say it: the NAACP and the League of United Latin American Citizens have become patsies for the insurance industry. "  Read More & Comment...

Competence Man vs. Confidence Man

04/20/2007 07:57 AM |

"Competence Man" as dubbed by Kim Strassel, is Mark McClellan (dubbed by Drugwonks as "the hardest working man in health care"). Here's what she had to say in today's Wall Street Journal:

Competence Man

By KIMBERLEY STRASSEL

Republicans won a big victory this week, shooting down a Democratic plan for more government-run health care. The GOP victors, and free-marketeers, might send their thank-you notes to Dr. Mark McClellan.

Dr. McClellan is the 43-year-old internist who, until recently, held the thankless job of running Medicare. He was handed the further thankless task of designing and implementing Congress's tepid 2003 Medicare reform. And he's the big brain who then wrung every last ounce out of that authority to create a striking new model for Medicare competition that is today not only performing beyond expectations, but is changing the political health-care debate.

High praise, yes, but borne out by this week's GOP defeat of a bill to allow the government to fix Medicare drug prices. That was a top Democratic promise this last election, as the party sought to play off public anger over health-care costs. Liberals saw it as an important step toward their all-government, health-care nirvana. Nancy Pelosi and Harry Reid also felt this was an issue on which they could once again roll Republicans, by flashing the impoverished-senior-citizens card.

Instead, Dr. McClellan's new model came online and wowed the older class. Private companies have flocked to offer a drug benefit, giving most seniors a choice of 50 innovative plans. The competitive jockeying has slashed prices from an expected $37-a-month premium to an average $22. The cost of Medicare Part D for taxpayers was 30% below expectations its first year -- unheard of in government. And Medicare Advantage, which allows seniors to choose between private insurers, has grown to encompass nearly one in five beneficiaries.

This success has rebutted Democratic criticisms of the drug benefit and shown up those who tar the Bush administration as incompetent. The program's success emboldened Republicans to vote for free-market health care this week. Democrats have seen flagging public support for their program of more government and fewer drugs. While Mr. Reid held his caucus together this week, some are worried about bashing a drug benefit that has an 80% senior approval rating. "Congress only wishes it had an 80% approval rating," chuckles former Democratic Sen. John Breaux, an author of the 2003 reform. "A lot of folks campaigned last year on 'We're going to fix this program,' only to be told by seniors, 'Wait a minute, it ain't broke.'"

None of this was inevitable, but goes back to the competent Dr. McClellan. President Bush came to town pushing Medicare reform, and had a shot at an historic overhaul. The GOP could offer the carrot of a new drug benefit, in return for opening the entire decrepit program to private competition. Instead, Bush and Co. became more interested in claiming credit for an $8 trillion entitlement, and settled for meager reform.

Dr. McClellan nonetheless took this pared-down opportunity and used it to show private competition can work. His success, in particular with the drug benefit, rests in two broad ideas. The first was to design a program that immediately attracted a critical mass of private players to provide price and choice competition. At the time, nobody thought that possible. Mr. Breaux remembers Congress worrying that so few private players would participate that whole areas of the country would lack private drug plans.

Dr. McClellan's solution was a program that gave companies maximum freedom to design plans, bundle drugs and turn a profit. He was a salesman, talking up the opportunities and even traveling to New York to reassure Wall Street. It worked, and by the first days of business most seniors were being courted by anywhere from 11 to 23 plan sponsors. Those numbers have only grown, creating so much competition that sponsors are eliminating deductibles, lowering premiums, offering more drugs. It's also led to smart cost-cutting and efficiencies; an estimated 60% of Medicare prescriptions are now for generics.

Dr. McClellan's other strategy -- and the flip side of the coin -- was to get seniors enrolled quickly. His team designed an Internet program that allowed seniors to punch in their information and examine the best plans. His agency reached out to local organizations -- church groups, community centers -- and enlisted their aid in explaining details. A call center at one point handled 400,000 plan questions a day. Today, some 90% of Medicare recipients are enrolled in the benefit, numbers that have further attracted private players, further spurred competition, further lowered prices. "This is how you come in under budget, increase satisfaction," says the man himself, Dr. McClellan. He adds, humbly, "Nobody should think this is perfect yet, but it's clearly accomplishing some good things."

Good things or no, the reforms are still at risk. There was a time when Democrats believed in Medicare reform, but now most prefer it as a political stick to beat President Bush. There are also liberals -- Henry Waxman, Pete Stark -- who understand this is a crucial moment in the national debate over government-versus-private health care, and will do what they can to sabotage the reforms.

Expect, therefore, more votes over Medicare's right to price-fix. If a broad bill can't pass, liberal politicians will instead target individual, high-cost drugs, arguing that since Medicare foots most of the bill for these products, it should have the right to "negotiate." The real goal will be to get any foot in the price-setting door, making it harder for private companies to craft flexible drug packages, and laying the groundwork for more price-setting down the road.

Expect, too, a push to starve the competitive programs of cash. Critics know how effective this is, having siphoned dollars out of the old Medicare Advantage program in the 1990s, causing private plans to drop out, and giving the program a bad name. Dr. McClellan's reforms, and a Republican Congress, have re-energized the program, but the key to future success is in the budget. Republicans would do well to spend more time touting the competition successes of the reform, rather than the drug giveaway.

In a perfect world, the Bush administration would never have swallowed that entitlement in the first place. In our imperfect world, it at least had the wisdom to hand the reform challenge to a guy who was able to demonstrate the merits of health-care competition, and optimistically, pave the way for broader reform down the road.

Great op-ed.

"Confidence Man" (like in FlimFlam Man") is Paul "Imus" Krugman of the New York Times. He earns this moniker because of the dishonest way he portrays the Part D benefit in today's edition of the Gray Lady, and his assertions that the NAACP and the League of United Latin American Citizens just aren't smart enough to know what's in their own best interests.  Read More & Comment...

Biotech Bootcamp

04/19/2007 09:49 AM |

CMPI Board member Steve Sammut is holding a biotech bootcamp for entreprenuers at Bio 2007 in Boston on May 7. Another board member, Atlas Venture partner Bruce Booth is on one of the panels.

Disclosure: Drugwonks does not receive any compensation for this plug and was not invited to speak. In fact, we were specifically told to stay away. Ok, so there is a TRO banning us from being within 200 yards of the session.

http://www.bio2007.org/Attendees/educational_sessions/EntrepreneurshipBootCamp1.htm  Read More & Comment...

Sheila Burke: Conflicted Over What a Conflict Is

04/19/2007 09:07 AM |

Here is Sheila Burke in her NEJM article describing the IOM Drug Safety panel she chaired:

"The IOM assembled a diverse panel of experts without ostensible bias or conflict of interest, none of whom were pharmaceutical industry employees."

Here is a description of Sheila Burke chairing the Smithsonian, which oversaw the conduct of Larry Small who used millions of taxpayer dollars to redo his home and hold lavish parties:

The Smithsonian Institution last year renewed a contract giving the Chubb Group more than a half-million dollars of insurance business annually while Lawrence M. Small, then the Smithsonian secretary, and Sheila P. Burke, the deputy secretary, held highly paid seats on Chubb's board of directors.

Small received cash and stock valued at $169,675 from Chubb last year, according to proxy statements filed with the Securities and Exchange Commission. He also received options to purchase 105,943 shares.

Burke received cash and stock valued at $194,676 from Chubb and options to purchase 56,000 shares, according to the SEC. Small and Burke sit on Chubb's compensation committee. Burke is also a member of Chubb's finance committee and pension and profit-sharing committee.

Small, who resigned late last month after seven years at the helm of the Smithsonian in the wake of questions about his salary and expenses, was set to receive $915,698 from the museum complex this year. Burke received $400,000 last year. A Senate committee holds hearings on Smithsonian compensation practices today. And another Senate committee investigation has raised questions about the Chubb-Smithsonian relationship."

Earlier this year Burke told me that a Nobel Prize winner would have been excluded from her IOM panel if he or she had worked for a drug company even if that person was an expert on drug safety. But I guess having someone rebuked by NIH for claiming a link between cancer and blood pressure meds and a hired gun for trial lawyers suing drug companies in drug safety cases is ok (Bruce Psaty) and taking money from a health insurer that would benefit from fewer new drug approvals is ok too.

Can we say ethically confused and compromised.  Read More & Comment...

The Sorrow and the Pity

04/19/2007 08:32 AM |

Virginia Tech sorrow and media SSRI hysteria notwithstanding, some important new science ...

Authors of a new comprehensive analysis of antidepressants for children and teenagers say the benefits of treatment trump the small risk of increasing some patients' chances of having suicidal thoughts and behaviors.

The risk they found is lower than the one the Food and Drug Administration identified in 2004, the year the agency warned the public about the drugs' risks in children. After the warning, U.S. youth suicides increased and some mental health experts said reluctance to try antidepressants might be to blame.

The new analysis includes data from seven studies that were not part of the previous FDA analysis, including two large pediatric depression trials that were unavailable three years ago.

Researchers analyzed data on 5,310 children and teenagers from 27 studies. They found that for every 100 kids treated with antidepressants, about one additional child experienced worsening suicidal feelings above what would have happened without drug treatment. In contrast, the FDA analysis found an added risk affecting about two in 100 patients.

Here's a link to the AP story:

http://www.chron.com/disp/story.mpl/health/4729234.html  Read More & Comment...

First Avian Flu Vaccine Approved...Will Go To MSM for Review

04/19/2007 08:04 AM |

Sanofi Aventis' vaccine division received approval for the first vaccine to protect against bird flu. According to the FDA the vaccine, has been approved for use only in adults aged 18-64 who are at a greater risk of being affected by the bird flu virus. The patients will receive a 90 microgram of shot initially and then another 90 microgram after 28 days.

Given that bird flu was first detected a few years ago, the speed with which a vaccine was developed is truly a marvel. And most of the vaccine will be donated or sold at cost. But don't expect any articles on that. Rather, expect a rash of media stories on whether the vaccine is being marketed to the right people and whether the researchers conducting studies on the vaccine's effectiveness received money from SA.

As I always say, no good deed goes unpunished.  Read More & Comment...

High Blood Pressure? Me Too!

04/19/2007 07:57 AM |

For those of you out there (yes, that means you Marcia Angell) who think we have "too many me-too drugs," consider yesterday's FDA adcomm vote on Avalide.

FDA advisers voted 7-0 in favor of approving the drug for use in controlling high blood pressure. (Avalide was initially approved only for hypertension patients who have failed other types of treatment.)

You've heard of hypertension, right? It's one of those made-up lifestyle diseases.

If the Me-Tooers were running the show, would Avalide have been approved in the first place? After all, do we really need another drug that treats hypertension?

Indeed we do -- and now physicians have a new, valuable, and on-label weapon in their fight against a major public health enemy -- high blood pressure.  Read More & Comment...

Warning Signs of Violent Behavior: On and Off Campus

04/18/2007 05:46 PM |

From the FBI.... I might be wrong but I don't see "taking an SSRI" on the list

1. A history of violence and/or being victimized
2. Threats of violence
3. An obsessive interest in weapons
4. A tendency to be isolated
5. The inability to get along with others
6. Excessive anger
7. Job loss
8. Breakup of a relationship
9. Alcohol and drug usage
10. Intolerance of differences
11. Gang affiliation
12. Poor attachment to school
13. Exhibiting impulsive behavior
14. Making violent drawings or writings  Read More & Comment...

Shooter Had Psychiatric Treatment..Sort Of

04/18/2007 05:32 PM |

As this story unfolds drugwonks will highlight what appears to be the critical factor in this tragedy in order to stave off the j'accuse from the anti-medication mob who are quick to blame ever senseless act of adolescent violence on the use of drugs to treat mental illness. Now in this case it would appear that the killer was psychotic -- not depressed -- and had been through the entire judicial-mental health system before being allowed go "outpatient" where he completely lost contact with any systematic care.

So we will be interested to see how that squares with efforts by the mob and the media to draw a direct link between a single medication that may or may not have been in his system at the time he carried out his plot and the massacre.

The lunatic fringe, led by Scientologists and quacks peddling 'natural cures' for everything from Alzheimer's to schizophrenia, are already polluting the blogosphere with lies and half truths claiming that Cho Seung-Hui was on SSRIs.
http://vitalvotes.com/blogs/public_blog/Could-Antidepressants-Explain-the-Virginia-Tech-Massacre--10928.aspx
http://winnipeg.indymedia.org/item.php?5048S

As countless studies show, such medications will make people with tendencies towards violence, less not more so.  Read More & Comment...

Will the VA Tech Shooter Trigger Attacks on SSRIs

04/18/2007 01:48 PM |

Our colleague Ed Silverman generated a lot of controversy with his post that rumors that the VA Tech killer was on medication at some point might trigger another attack on drug companies about the alleged dangers of SSRIs.

Here's my take:

While I pin the blame on the media for over-hyping and misrepresenting the risks of SSRI's -- particularly the clinical trials involving children who have co-morbidities, misdiagnoses, etc. -- the fact is tha fear sells paper just as violence sells video games. The fact is, that as horrible as this campus shooting is, school related shootings are rare and violence on college campuses has declined because of increased security, increased counseling, etc., etc. And moreover, according to FBI crime stats, a college campus is ten times safer than than the US as a whole.

While I am on the subject, and excuse me for saying it and maybe I have a little more leeway for saying this because of my own family experience, but I am tired of the press using perpetually enraged parents who blame the death of their kid's on prescription drugs. There are thousands of children who take their own lives who who never get medication and thousands more who have pulled themselves from the abyss because of such drugs. Who are they to lecture the rest of us about the motives of drug companies and science of medicine. I am sorry for their loss but I have been through hell too. They have no monopoly on sorrow and portraying them as victims of antidepressants is inaccurate and unfair. Give it a rest!

You don't want your kids to be on anti-depressants. Fine. But stop pouring gasoline on a subject with ignorance and fear. And don't exploit a tragedy by using it to scare other parents into seeking appropriate care for their kids. As for the media, you have the facts now. Use them.  Read More & Comment...

Is There a Downside to a Drug Ad Ban?

04/18/2007 12:39 PM |

What if fewer people find out about important new medicines while at the same time critics pan new products and scaremongers push panic about side effects leading to those quacks who sell to good to be true cures to rake in profits at the expense of the sick and scared?

Power abhors a vacuum. So does information.  Read More & Comment...

David Graham: Public Health Enemy

04/18/2007 09:17 AM |

In the wake of the terrible tragedy at Virginia Tech comes yet another study demonstrating that the use of anti-depressants in adolescents -- carefully monitored -- are useful in treating various forms of depression, anxiety, panic disorder, etc. No major paper or media outlet which gave David Graham or others front page coverage of the threats or the misrepresentation of the dangers of SSRIs are now giving the benefits of these medications the same top of the fold treatment.

For those of you who want to see how such fear mongering can lead to a decline in the use of effective treatment and therefore an increase in violent behavior that in fact leads to suicide and tragic death, we now present one Graham's typical statements on SSRI's

"With the SSRIs [Selective Serotonin Re-Uptake Inhibitors, the class of antidepressants including Prozac and Paxil], I think FDA pulled a fast one on the American people. Because they said, �we are using our most powerful labeling, our most powerful medicine: we�re putting a black box around it.� But it doesn�t change physician behavior. People are as unsafe after the labeling goes into effect as they were before.

With the SSRI labeling, people are actually more deceived. Because the labeling says that the risk of suicidal thoughts and behavior in children is 1-2 percent. But FDA�s own senior managers admitted at an open public advisory committee meeting that our clinical trials don�t capture suicidal thoughts and behavior. So what we know about it is what has been voluntarily reported. There are lots more out there, we just didn�t measure them. They have evidence from an NIH clinical trial that the risk is more like 8 percent. "
http://multinationalmonitor.org/mm2004/122004/interview-graham.html
Members of Congress and senior officials of the FDA should be ashamed of themselves for giving Graham the chance to not only rant on about Vioxx and SSRIs but to make the same claims about Ketek and drugs for schizophrenia.  Read More & Comment...

Stabenow-nothings in Congress

04/18/2007 07:29 AM |

My latest oped on how Democrats (mostly, but not all) -- led by the incredibly clueless Debbie Stabenow -- are subverting medical science (and proper spelling) for the sake of ideology in the area of pharmaceutical regulation. And it's going to get worse this week and the next when the same Jacobins seek to destroy what is now sensible drug safety legislation with amendments on drug importation and other nonsense. Maybe AARP will offer me another pedometer for calling my Congressman on these important issues.

Or maybe not.

http://washingtontimes.com/op-ed/20070417-091721-8233r.htm  Read More & Comment...

Gates to the Critical Path

04/18/2007 06:57 AM |

A new IMS Health report posits that, “The billions of dollars thrown at global health problems by the Bill & Melinda Gates Foundation are changing the game in drug discovery, posing big challenges to the world's top drug makers.”

"Pharma companies need to develop an explicit strategy to deal with this phenomenon," IMS said in its annual Intelligence.360 report on factors shaping the industry.

According to the report, the foundation’s $60 billion gives it plentiful resources to compete in the medical research arena with both government-funded institutions and commercial pharmaceutical firms.

IMS believes that, even if drug companies succeed in making key discoveries first, they may still find it attractive to partner with the Gates Foundations, from a practical and public relations point of view.

Well, that’s all to the good – but what the report doesn’t mention is that discovery and development is still a very difficult proposition.

Drugwonks challenges the Gates Foundation to become a major player in the FDA’s Critical Path program – because the best way to get new cures to market faster is to develop the 21st tools required to expedite discovery and development.

Here’s the link to the Reuters story on the IMS report:

http://news.yahoo.com/s/nm/20070417/hl_nm/gates_pharmaceuticals_dc_1  Read More & Comment...

statin drugs

04/17/2007 10:51 PM |

Late last month, an important study in JAMA showed that patients in a high LDL cholesterol group from 130 to 160 did not show a progression of carotid plaque when receiving rosuvastatin compared with control. This study was a breakthrough in terms of primary prevention though the results are not surprising, and many internists, myself included, were already treating many of the members of this group with statins. Carotid plaque is predictive of coronary plaque, and previous studies have shown plaque stabilization with atorvastatin in patients with heart disease leading to a diminishing of subsequent cardiac events. (secondary prevention)

Here is the new JAMA study on rosuvastatin - it would be interesting to follow this up with a study that looked at whether bringing down LDL to less than 80 with diet alone, gave the same results in terms of plaque as when a statin is used.

http://jama.ama-assn.org/cgi/content/full/297/12/1376  Read More & Comment...

HELP Desk

04/17/2007 10:52 AM |

Markup tomorrow for the Food and Drug Administration Revitalization Act. No importation codicil – but, unfortunately, it may yet appear as a floor amendment.

Some topline highlights:

Title I -- Prescription Drug User Fees

Title I establishes an overall amount for user fees of nearly $393 million for 2008 (which will be adjusted upward based on 2007 workload). It includes the expansion of use of drug user fees by nearly $30 million for post-approval drug safety programs.

Title I also includes the FDA-industry proposal to create a voluntary user fee program under which drug companies can submit direct-to-consumer television advertisements to the agency for review before they are distributed.

Title II -- Drug Safety

Subtitle A -- Risk Evaluation and Mitigation Strategies (REMS)

This subtitle establishes a system of routine active surveillance for post-market drug safety through a public-private partnership. The partnership will aggregate data from Federal and private health databases containing information for at least 100,000,000 covered lives and support the analysis of utilization and safety data from these databases. The establishment of this system will be supported with up to $30 million in appropriations.

Given the ability of this active surveillance system to identify and assess drug risks, most drugs and biologics will not need anything further than this system and the drug label to appropriately manage risk. However, some drugs and biologics will need additional tools to manage serious risks, and these products will be approved with risk evaluation and mitigation strategies (REMS). Sponsors would propose a REMS and FDA would approve it after structured negotiations, if necessary. The REMS will be reviewed at 18 months and three years, as well as in labeling supplements and when FDA requests a review.

Additional Elements —When more is needed, a REMS may include tools to assess, communicate about, or manage risks. The bill contains clear standards detailing the appropriate application of each tool. These standards ensure that new FDA authorities are applied narrowly, and only as necessary.

A REMS would be assessed in response to new information about a serious risk, and could be modified, including by reducing the stringency of elements, in response to new information.

Resources -- Increased drug user fees would be used to review REMS and for FDA’s general drug safety surveillance. This subtitle increases user fee revenue by $50 million over the agreement between industry and the FDA to fund drug safety activities.

Subtitle B -- Reagan-Udall Foundation for the Food and Drug Administration

Subtitle B establishes a foundation to lead collaborations amongst the FDA, academic research institutions, and industry directed to supporting the FDA’s mission. Collaborative research projects will be selected that are designed to bolster R & D productivity, provide new tools for improving safety in regulated product evaluation, and in the long term make regulated product development and safety more predictable and manageable. The Foundation will be financially supported by industry and philanthropic donated funds.

Subtitle C -- Clinical Trials

To enhance patient enrollment and provide a mechanism to track subsequent progress of trials, the data bank at www.clinicaltrials.gov will be expanded to include all phase II and later trials, and to include devices. Currently, only clinical trials of drugs for serious and life threatening conditions are required to register in the data bank.

In addition, to ensure that results of trials are made public, and that patients and providers have the most up-to-date information, results information would be added to this database. Information would be added only after the product in question has been approved or cleared for marketing. Results information would first come from existing FDA and NIH documents, as well as peer-reviewed scientific publications. A negotiated rulemaking process would be used to determine when and how to add results information not captured under those conditions.

Subtitle D -- Conflicts of Interest

Subtitle D requires disclosure of conflicts of interest of advisory committee members prior to an advisory committee meeting, and greater efforts by FDA to identify and recruit members of advisory committees.

Title III -- Medical Device User Fees

Title III is reflective of the agreement between FDA and industry regarding the total list of issues within their agreement from the time of the publication of the Federal Register notice. Given that some of the submitted language does not track the intent of the agreement, we expect to provide further improvements to the language at a later date. Those improvements will be agreed to by both FDA and industry.

Per the agreement between FDA and industry, it establishes an overall amount of $287 M of user fees over five years, with $48 M in 2008. This is coupled with a fixed 8.5% annual increase (with no other adjustors) and a further reduction of fees for small business.

Title III also includes the FDA-industry proposal on third party inspection improvements to ensure that the program works more efficiently and clarifying that entities can register and list electronically.

Title IV -- Pediatric Medical Products

Subtitle A -- Best Pharmaceuticals for Children

Subtitle A would reauthorize the Best Pharmaceuticals for Children Act and improve its provisions in order to make it more effective at ensuring that drugs for children are safe for pediatric populations. BPCA generally provides six months of additional exclusivity to drug manufactures to encourage the determination of safety and efficacy of drugs in pediatric populations. The bill contains an incentive of three months of additional exclusivity if US sales of the active moiety by the innovator and its affiliates exceed $1 billion annually at the time written request for study is issued. The bill is a five-year authorization and will expire in 2012. No PDUFA funds can be used for BPCA studies. The Secretary may send declined requests for study to the NIH Foundation if funds are available.

Subtitle B -- Pediatric Research Improvement

Subtitle B would reauthorize the Pediatric Research Equity Act and improve its provisions in order to make it more effective at ensuring that drugs for children are safe for pediatric populations.

In order to improve coordination with the pediatric exclusivity provisions of the Best Pharmaceuticals for Children Act (BPCA), PRIA would consolidate an internal FDA committee to review all issues of pediatric-related labeling and assessments. Doing so ensures that a drug that falls under PRIA or BPCA is reviewed not only by experts for that particular drug, but experts with pediatric expertise. PRIA will sunset in tandem with BPCA in 2012. If a company chooses not to pursue pediatric exclusivity for an already marketed drug under the Best Pharmaceuticals for Children Act, and no study is performed through NIH, then the Secretary has the authority to require the submission of pediatric data for such drug. PRIA streamlines this process and helps get essential pediatric data for important drugs, while preserving the ability of companies to meet and discuss testing with the agency.

The bill would require two reports – one from the Institute of Medicine and one from the GAO – that would allow us to have better data on the number and ways in which the pediatric rule is used, and evaluate its contributions to ensuring overall pediatric drug safety.

Subtitle C -- Pediatric Medical Devices

Subtitle C modifies the existing humanitarian device exemption (HDE) for medical devices to allow profit for HDE-approved devices specifically designed to meet a pediatric need. Maintains existing requirement that a humanitarian use device is limited to one that treats and diagnoses diseases or conditions that affect fewer than 4,000 individuals in the U.S. per year. No profit will be allowed for a device used in more than 4,000 individuals. The HDE exemption expansion sunsets in 2013 and a GAO report assessing the HDE exemption expansion and its impact on patients and manufacturers is required.

The FDA’s Office of Pediatric Therapeutics will acquire enhanced authority to collaborate with NIH, AHRQ, and subject matter experts in order to assess pediatric device R&D needs.

Demonstration grants, with tracked results, will be established for non-profit consortia to promote pediatric device development, manufacture and distribution. The bill grants explicit authority to the FDA’s Pediatric Advisory Committee to monitor pediatric devices and make recommendations for improving their availability and safety. This approach incorporates several recommendations of the Institute of Medicine including improving the postmarket surveillance of medical devices used in children and expanding public access to postmarket studies of pediatric medical devices.

Still plowing through the details – more to follow.

FDA package posted here:

http://help.senate.gov/Hearings/2007_04_18_E/S1082.pdf

Have a look and let the debate begin!  Read More & Comment...

Hey AARP Where's My Pedometer?

04/17/2007 10:18 AM |

In an effort to entice me to join, AARP has sent me two emails a day offering me a free pedometer if I become a member. That is one email more a day than I get from the site offering me soft-tab Cialis. AARP has also sent me emails urging me to join in a national call in to support Medicare price controls but there was no toll free number. What if I was on a fixed income and had to choose between food and a phone call?  Read More & Comment...