Latest Drugwonks' Blog

The Task of the Ask

  • 11.15.2005

According to the new FDA White Paper on PDUFA, more and more companies are seeking early advice from agency. FDA’s research has shown that this increased communication results in a more informed and efficient drug development process for industry sponsors. Since 1999, requests for meetings to discuss products stalled in development have increased more than 200 percent. Requests for consultations to review clinical milestones and next steps in the development process are up more than 60 percent. In the past two years, the number of industry-requested meetings scheduled between FDA and industry sponsors has almost doubled, from 1642 meetings in 2002 to 2132 meetings in 2004. With more frequent FDA guidance and consultation, the quality of new product applications has improved, and fewer review cycles are needed. Before PDUFA, an average of two review cycles was needed to gain FDA approval for an NDA. In 2004, thus far the majority of NDAs have been approved after just over one review cycle.

Those who think the FDA should view the pharmaceutical industry as the enemy misunderstand (and at great peril) a crucial 21st century regulatory paradigm — collaboration advances the public health. As James Thurber said, “It is better to know some of the questions than all of the answers.”

Part D-Day

  • 11.15.2005

And they’re off.

Good News/Bad News

  • 11.14.2005

The good news is that one of the world’s largest pharmaceutical wholesalers (McKesson) is tightening up its supply chain. The bad news is that they weren’t going to make it public. The story became public when McKesson’s letter to Kevin Fagin — whose son received injections of a counterfeit anemia drug — did the right thing and made it public. (I recently testified with Mr. Fagin in front of the Government Reform Committee about the growing problem of coutnerfeit prescription drugs.)

The letter, from Ivan D. Meyerson, the general counsel, said that “on a going forward basis, [drugs] will only be purchased directly from the manufacturer or from the manufacturer’s designated sole distributor.” The letter states that the company has “no current intention of announcing this policy to the public.” The new policy means that the three top wholesalers that account for a total of more than 90% of medicines distributed in the U.S. have taken steps to cut off purchases from so-called secondary wholesalers. Such suppliers don’t purchase products directly from drug makers and create an opening for illicit knock-offs to enter mainstream channels. In the last year, Cardinal Health Inc. of Dublin, Ohio, and AmerisourceBergen Corp. of Chesterbrook, Pa., announced they would end purchases from the secondary market.

Mr. Fagin isn’t a policy wonk or an elected official or a pharmaceutical industry lobbyist. He’s a good man with a lot of courage. Thank you Kevin.

As sure as Christmas music in the mall signifies the coming of the holidays, so too do silly lawsuits and testosterone-laden accusations signal the budding of the nascent 2006 political campaign season. As the giant spruce goes up in Rockefeller Center, Montgomery County (MD) Executive Douglas M. Duncan announced that the county will sue the Food and Drug Administration to force it to allow county employees to import drugs from other countries.

It’s beginning to smell a lot like — well, it’s just beginning to smell.

According to The Washington Post, the county’s lawsuit “faces long odds.” In late September, a federal judge threw out a similar action brought by Vermont. On Nov. 2, that state’s attorney general decided not to appeal. But, hey, what’s precedent when you’ve got propaganda? “I am disappointed, but not surprised, that the Bush Administration would deny hard working people access to cheaper prescription medications,” Duncan said in a statement.

Mr. Duncan, it seems, is so worked up about the issue that he forgot to sign the legislation. He said that he’ll let the law go into effect without his signature — but will not implement the measure without FDA support. Now is that commitment or what!

Council President Tom Perez, the architect of the council’s bill, angrily accused Duncan of trying to derail the effort. “I am really reaching a point where people will lead, follow or get out of way. I will implement it out of my own office if I have to,” said Perez, who is hoping to use the prescription drug issue if he runs for state attorney general next year.

And that, dear reader, says it all.

According to the British Medical Journal, the National Institute for Health and Clinical Excellence (NICE) has developed a more rapid process for assessment that will be used initially for lifesaving medicines, including several cancer drugs.

The new “single technology appraisal” process will enable NICE to develop guidance on drugs selected for rapid assessment within eight weeks — much more quickly than the current average of 18 months. It will initially be applied to lifesaving drugs that have already been licensed and to new lifesaving medicines close to the time that they first become available.

That’s the good news.

The new appraisal process will initially be applied to 14 drugs — 13 of which are cancer drugs — that have already been referred to NICE. These include docetaxel (Taxotere) for breast cancer; paclitaxel (Taxol) for breast cancer; rituximab (MabThera) for non-Hodgkin’s lymphoma; trastuzumab (Herceptin) for breast cancer; and bortezomib (Velcade) for multiple myeloma.

That’s the bad news — that these treatments are still not cleared for use in England.

As Joanne Rule, chief executive of the cancer information charity CancerBACUP, said, “These proposals represent a bold reform package for the future, but they don’t solve the problem of the backlog of new cancer treatments currently held up at NICE.” She added, “NICE should issue interim guidance on cancer treatments already approved for use in Scotland, and it’s crucial that the government make it crystal clear that doctors can prescribe licensed cancer drugs now.”

NICE guys must finish first.

According to a new GAO report to Congress, Americans import a “substantial and increasing” number of illegal prescription drugs, but efforts to stop the sales remain scattershot. Estimates given to Congress range from 2 million to 20 million packages a year. The “very limited” information prevents regulators from directing resources efficiently to prevent shipments of addictive substances or other medications that could be harmful, the report says.

Well, duh.

The GAO study was begun at the request of Senator Norm Coleman (R, MN.), chairman of the Senate Permanent Subcommittee on Investigations, and Representative John D. Dingell (D, MI). Here’s what Mr. Dingell had to say, “While rogue websites continue to send their drugs into the U.S. with impunity, the agencies most responsible for stopping this chaos are completely out of ideas.”

I suppose that members of Congress (such as Rahm Emanuel, Dan Burton, Joanne Emerson, Byron Dorgan and Gil Gutnecht), governors (such as Tim Pawlenty, Rod Blagojevich and Jim Doyle), hack local politicians (like Tom Perez of Montgomery County, MD and David Catania of the DC City Council), and organizations (such as Families USA and the AARP) trumpeting the mantra of drug importation has nothing at all to do with the problem. Add to that zero additional budget dollars from Congress to deal with the problem and any surprise or righteous indignation is, well, just specious.

Folks, you’re either part of the solution or part of the problem.

Four fruitcake bakers have petitioned the FDA to cut the serving size for fruitcake by two-thirds. The bakers’ 13-page petition calls on the FDA to “describe fruitcake as the food commonly known as fruitcake.” It underscores the product’s uniqueness (“Gertrude Stein would say ‘A fruitcake is a fruitcake is a fruitcake!’ “). It also clarifies who eats the concoction (“Fruitcake is consumed by all populations, but rarely by infants.”), and it distinguishes fruitcake from other high-density cakes. (“No products are ‘closely related’ to fruitcakes. They are sui generis and for decades have been recognized by all population groups in the U.S.”)

What’s next — Congressional hearings?

The following is a press release from our regulatory cousins over at the MHRA …

“The Medicines and Healthcare products Regulatory Agency (MHRA) is getting tougher on misleading advertising materials by drug manufacturers. The MHRA will now vet advertisements for any newly licensed medicine before they are advertised. Under previous arrangements, the MHRA only vetted advertisements for some new medicines on the basis of a risk assessment. In line with the recommendations laid down this year in the Health Select Committee’s Report on The Influence of the Pharmaceutical Industry, the MHRA now pre-vets promotional material for all new active substances.Vetting details were outlined yesterday at an MHRA seminar in London, where healthcare professionals were told that the period of vetting of all advertising for a new medicine will normally be three to six months, but could take longer should any problems be identified.”

As Laurence J. Peters reminds us, “Bureaucracy defends the status quo long past the time when the quo has lost its status.”

Payor-genomics

  • 11.08.2005

Kudos to NY Times reporter Andrew Pollack on a first class piece about the immediate possibilities of pharmacogenomics — and the road blocks to achieving them; most notably the lack of enthusiasm from insurance companies. Here’s what Mr. Pollack has to say:

“Health insurers are in some cases balking at paying for pharmacogenetic tests. It might seem that insurers would welcome tests that allowed side effects to be avoided or drugs to be used only in patients who would benefit from them. A test for a single enzyme like 2D6 costs $100 to $500. Yet Blue Cross Blue Shield concluded that the usefulness of the metabolism tests was not established. In particular, the insurer said, there have been no prospective studies, in which some patients are given the test and others are not to see whether those who are tested do better.”

How unfortunate that the insurance industry (and if I generalize mistakenly, please let me know) remains caught up in a 20th century acute care model when our nation so desperately needs a laser beam focus on the chronic side of the health care equation. After all, that’s both the driver and the rationale behind Medicare modernization.

I guess the insurance industry didn’t get the memo.

Nice job Andy.

Here’s the web link to the full article:

http://www.nytimes.com/2005/11/08/health/08phar.html?8hpib

I.P. Owed.

  • 11.07.2005

First they came for pharmaceutical IP, but I wasn’t a pharmaceutical manufacturer. Then they came for the software IP, but I wasn’t a software developer. Then they came for entertainment IP, but I wasn’t a music producer. Then …

WASHINGTON (Reuters) — The U.S. Trade Representative could no longer craft trade deals making it harder to import American-made pharmaceuticals from nations such as Canada under a measure approved by congressional negotiators on Friday.

The compromise legislation is aimed at keeping the rancorous issue of drug reimportation out of trade pacts the United States reaches with other countries.

The Bush administration, which opposes the measure, said it would “substantially weaken U.S. efforts to protect intellectual property through U.S. trade agreements.”

The administration also said it would infringe on the president’s authority to negotiate trade deals.

The bill must be passed by the House and Senate before being sent to President George W. Bush for his signature.

The issue surfaced a few years ago in a free-trade agreement with Australia. The pact was approved overwhelmingly, despite the objection by many lawmakers to a provision that prevented the importation of drugs from Australia on which U.S. drug companies held patents.

CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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