States petition FDA on generic insulin, human growth hormone

I don't have a lot of time to elaborate on this topic today, but I will say that I am working on a freelance article on this topic for a major diabetes publication. I have written previously about the topic of potential generics of human insulin (see this link for my post).

Lets just say that for patients with type 1 (insulin dependent) diabetes, our options are clearly being limited by the FDA's lack of leadership on this issue (while Europe's Regulatory Drug Agency has already moved ahead on this issue). I have written to my Senators and Representatives and asked them NOT to approve Andrew von Eschenbach, MD as the permanent head of the FDA, as under his leadership, the agency has repeatedly delayed efforts to move ahead on this (as well as several other issues, including what is known as Plan B contraceptive) and generally turned the FDA into a political agency for President Bush rather than an agency that governs food and drugs, something which the FDA should not be. I would encourage others who agree with this sentiment to urge their Congressional representatives to do the same.

Although insulin analogs are not up for patent expiration until 2014 and will likely account for the lion's share of the market, old standbys such as Lente, Ultralente are being phased out, and one has to wonder whether NPH might soon follow. While many recently-diagnosed (those dx'd within the past 15 years) are critical of these insulin preparations, two generations survived on these without problems, so the long-term effiacy of these has clearly been proven, while the jury is still out on analogs, particularly long-acting analogs like Lantus and Levemir.


States petition FDA on generic insulin, human growth hormone
Fri, Aug 4, 2006

WASHINGTON (Reuters) - Four governors, looking to ease drug costs under state programs, petitioned the U.S. Food and Drug Administration on Thursday to provide guidelines for generic versions of insulin and human growth hormone.

The FDA has been developing regulatory advice for companies who want to make cheaper copycat versions of the injectable drugs since 2001, but recently delayed issuing final guidelines.

In their petition, the governors joined other critics in accusing the agency of dragging its feet.

"We have been informed that there are no scientific reasons for delaying the issuance of the guidance documents FDA already has drafted," the bipartisan group of governors wrote the FDA.

Democratic Govs. Kathleen Sebelius of Kansas and Jim Doyle of Wisconsin joined Republicans Tim Pawlenty of Minnesota and James Douglas of Vermont in signing the petition.

"There is no legal or regulatory obstacle to the immediate issuance of these guidance documents," they added.

Both insulin, used to treat diabetes, and growth hormone, used to treat growth disorder, are protein-based drugs known as biologics.

With a growing number of diabetics in the Unites States and tightening state budgets, the governors are eager for cheaper insulin alternatives.

"The FDA's delay in informing manufacturers of the requirements for obtaining approval of therapeutically equivalent versions of insulin and HGH has cost the states and other health-care providers hundreds of millions of dollars," the petition said.

About 7% of Americans, or nearly 21 million people, have diabetes, according to the National Institutes of Health. Growth disorders are more difficult to measure. Not all those diagnosed with either condition are treated.

Many states pay for prescription drugs through the joint federal-state Medicaid program for the poor as well as special insurance programs for children.

Because insulin and growth hormone were approved decades ago as regular drugs, supporters argue the FDA has the legal authority to approve generic versions.

The issue of cheaper alternatives to other biological drugs remains in limbo. Brand name companies say biologics are too complicated to copy.

In May, the agency approved a generic version of human growth hormone made by Novartis AG's Sandoz unit called Omnitrope but said the decision did not set any precedent for other biologics.

The FDA did not have immediate comment on the petition.

The Generic Pharmaceutical Association supported the governors' move as a way to force the FDA's hand. The Biotechnology Industry Organization, which represents brand name makers, did not have immediate comment.

URL for this article:
http://today.reuters.com/news/articlenews.aspx?type=healthnews&storyID=2006-08-04T121631Z_01_MAR381259_RTRUKOC_0_US-STATES-PETITION.xml


... And some recent history on this subject:


FDA won't release generic insulin guide
By Andrew Bridges, Associated Press Writer
April 6, 2006

The Food and Drug Administration will not release long-delayed guidelines specifically for the production of generic versions of insulin and human growth hormone, according to an agency letter.

The guidelines, in draft form since 2002, would help manufacturers seeking to produce generic versions of insulin and human growth hormone. It is estimated that $3.5 billion is spent on the two drugs each year; introduction of those lower-cost versions could reduce that total by hundreds of millions of dollars.

The FDA long had suggested the guidelines were forthcoming. But the agency, in a reply to a Feb. 10 letter by Sen. Orrin Hatch, R-Utah, and Rep. Henry Waxman, D-Calif., said it now intends to publish broader guidelines that apply to all generic versions of protein-based drugs, also known as follow-on protein products.

Waxman said the reply by associate commissioner for legislation Patrick Ronan left him "extremely disappointed." He and Hatch say insulin and growth hormone should be considered separately, given their simple structures and long history of safe use.

Waxman said in a statement that the FDA's action was "a misguided step that will only result in further delay" of rules for low-cost generics.

The guidance would spell out requirements for drug makers before they could win approval of generic versions of insulin and growth hormone, presumably at reduced prices, without repeating the expensive human trials originally mandated for brand-name versions.

With traditional chemical drugs, companies simply have to show that a generic version works the same way as a brand-name original to gain FDA approval.

The FDA first announced in 2001 that it was working on the guidelines to produce generic versions of insulin, widely used by the growing ranks of diabetics, and human growth hormone, used to treat growth deficiencies and other conditions.

The FDA's letter of reconsideration was obtained Thursday by The Associated Press. The disclosure comes days after the FDA published a brief analysis that showed the availability of just two generic versions of a brand-name drug can cut in half the price consumers pay for that medicine.

Unlike chemical drugs, biotech drugs -- also called biopharmaceuticals or biologics -- are based on proteins derived from living cells. They account for a growing percentage of Medicare and Medicaid costs, according to the Generic Pharmaceutical Association, which supports the guidelines' release.

The Hatch-Waxman Act of 1984 helped spawn the generic drug industry.

On the Net:
Food and Drug Administration: http://www.fda.gov/

URL for this article:
http://www.boston.com/yourlife/health/aging/articles/2006/04/06/fda_wont_release_generic_insulin_guide/