New Drug Approvals Are On The Rise, So Far
7 CommentsBy Ed Silverman // May 15th, 2008 // 7:00 am
The 29 new drug application approvals by the FDA year to date through April represent the highest levels since 1998 and 2000. This figure is up dramatically from 16 in the year-ago period and the 10-year average of 24, writes Jim Kumpel, a healthcare analyst at Friedman Billings Ramsey in a research note this morning. The results also match the four-month highs attained in 1998 and 2000.
Taken at face value, NDA approvals reflect a more active FDA in 2008. However, an increasing amount of this uptick reflects incrementalism, with 10 of the 29 approvals coming from new manufacturers for existing drugs, approvals of drugs already marketed, or new formulations of existing compounds (versus three of the 16 through the first four months of 2007). Aside from those approvals, the comparison would have been 19 year to date in 2008 versus 13 in the comparable year-ago period.
NME approvals, meanwhile, are still moribund. The three NME approvals through April match the low water mark only previously reached in 2002. The April NME approval figure was four in 2007 and an average of six over the last 10 years.
“We view NME approval trends as a more critical metric than overall new drug approval trends because NMEs represent novel compounds carving out entirely new pharmaceutical niches. These are the compounds that break new clinical ground and require the most effort in educating physicians, patients, and payers,” Kumpel writes.
Looking ahead, he posits that, new hires over the next few months will likely be less productive than the average FDA staffer, “it may be reasonable to expect a rebound in both NDA and NME approvals in 2009.”
Dan
When Competition Does Not Benefit Consumers
“But corruption is neither need based nor greed based. It’s simply opportunity based.” —–
Billy Tauzin, president and C.E.O. of PhRMA, the pharmaceutical industry’s most powerful lobbying group, as Mr. Tauzin stated in Boston recently.
It has been said by others that the pharmaceutical industry should not have government regulation or interference from our government at all because that would drastically limit if not eliminate innovation as well as our health care choices and options, both from the perspective of the doctor and the patient, so the public has been told often by others. So, according to some, the public’s health would be limited and possibly harmed. As with other issues we face as citizens, this is another attempt by these others to apparently install fabricated fear in our minds- void of any proof or reason.
As it has turned out, the pharmaceutical industry’s lack of innovation in particular has happened and they have appeared to do this on their own, overall.
Over the past several years, those few meds created and FDA approved with true therapeutic advantages happened by discovery with government involvement in over half of these meds with clear clinical advantages for certain patients. Conversely, of the new chemical entities approved lately and developed by drug companies, over 50 percent of these have microscopic therapeutic advantage for patients, so I understand upon information and belief. This inefficient drug development by the pharmaceutical industry has created what is now the dominant development strategy of drug companies, and this strategy is known as the intentional development of what are phrased, ‘me too’ drugs.
These drugs essentially are small molecular variations of the original molecule in a particular class of medications. In other words, they tweak the original molecule in order to obtain patent rights for their now new drug project. This me too objective of drug companies now accounts, I believe, for about 80 percent of the research budgets of drug companies. And because the FDA only requires a potential med to be superior to a placebo in their mandatory clinical trials, usually these me too meds are approved- regardless of their necessity for others, or the need for such drugs.
And me too drugs are selected by the drug company for their potential blockbuster status as well as the speculated growth of a particular market, which means making over 1 billion dollars a year on such a drug, at least. For example, statin drugs, for high cholesterol patients, is a multi- billion dollar market. As a result, there are several statin meds now available for use by doctors to prescribe to their patients. Yet, arguably, me too drugs are all essentially very similar in regards to safety, efficacy, and cost, regardless of the class referred to so often saturated with me too meds, with few exceptions. The differences overall are minor once again with most me too drugs. As aggressive marketers, the makers of these meds are suspected of doing a bit of publication planning, it is suspected, to falsely claim superiority of their newly approved me too drug over all the other drugs in a particular class. Also, other classes of meds with several me too drugs may include SSRI anti-depressant drugs, as well as those meds for hypertension. There may be a dozen drugs in a particular class of medications that are all essentially the same in regards to their treatment abilities for patients with such disease states that they treat.
Now, there may be cases where a patient tolerates one drug in a class over another for unknown reasons, so in these few cases, these me too drugs occasionally are beneficial for patients, but should absolutely not be a primary objective of the drug companies to create them as often as they do. Instead, true innovation and discovery should be the focus of pharmaceutical companies, and it does not appear to be the focus of the pharmaceutical industry, presently.
Further vexing is that competition in the pharmaceutical industry amazingly does not and has not been of any financial benefit for the consumer, as competition normally does create. This fact is normally demonstrated with other industries and is the apex of business operations. This pharmaceutical industry model is an exception, and the reason for this remains an unknown, as far as the etiology of being deprived of this costly environment of drug spending.
This progressive marketing paradigm of the pharmaceutical industry, such as the creation of me too meds solely for their own profit, clearly illustrates their focus on these issues over true research and science, so it seems. Innovation, along with ethics, use to define this industry. Sadly, it seems this is not the case today, which ultimately and potentially deprives potential treatment methods potentially for the public health. Yet hopefully, such historical qualities of drug companies will return some time.
Dan Abshear
Lilli
Hi Dan,
I am still not quite sure whose side you are on?
Nathan
Lilli,
Why are you insisting on “picking sides”? This isn’t a battle. We are all interested in working to better the health of mankind. We just have different views of how to achieve that goal.
Lilli
Nathan,
Why do attack Me?
< About Dan Read the following:
Dan Abshear
living in Wentzville, MO
Have spent my working life in various aspects of the health care system for decades. Was a medic in the military in the past. And I’m a health care advocate and legal consultant as well, which I enjoy.
Education/Experience: Columbia, B.A.- Behavioral Sciences
Interests: Writing, Reading, health and legal advocacy/consulting, bicycling, parenting, and questioning authority
Motto: Awareness is a catalyst for reality.
Affiliations: National Physician’s Alliance, Community Catalyst, Consultant for New Jersey Star Ledger
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Dan
Nathan, thank you
Lilli, you seem concerned.
Lilli
It is a waste of my time to speak to individuals involved with Big Pharama!
Lilli
clazy
NMEs may be moribund in the US, but they’ve been rising in the EU. From 2003 to 2006, the numbers were 36, 45, 39, and 63. In the US, on the other hand, the numbers were 28, 30, 31, 19. (Parexel) I couldn’t tell you why.