DD Support Board and Research Team

[shajandr]

And a small ray of sunshine:

https://www.msn.com/en-us/news/money/fda-is-green-lighting-drugs-at-breakneck-speed-and-raising-alarm/ar-BBXRMmR

I've posted here in the past that one of the very, very few Federal agencies, departments, commissions, entities that more-or-less works properly is the FDA. The other main one that works at least decently is the USPTO.

I have had many involvements in FDA actions and interactions, and it is mostly professionally run. Nott up to private business standards, butt compared to disasters like most other Federal agencies it's at least responsive, reasonable, and staffed more-or-less with competent people (there have been some notable exceptions, butt it's poor form to name names). The FDA is stricter (in general) in approvals and in approving clinical trial plans than, for example, the EMA (European Medicines Agency), which is why many clinical trials are done in Europe because the EMA is more lenient on pre-trial evidence needed before commencing a clinical trial of a new drug candidate or device than is the FDA (generally speaking), so you can often start clinical trials faster if you apply to the EMA for clinical trial approval. All a company needs is an EU business entity to apply for a clinical trial.This is why I've been managing director of shell corporations in the EU, principally via the UK's Companies House - to establish corporations in the EU solely to be eligible for a US-based company to apply to do clinical trials in the EU under a EMA clinical trial license. It's a silly way to do things - each shell corporation has to file taxes each year (on typically ZERO income) and declare One Pound Sterling as the authorized capital - classic bureaucratese of government - butt nott a huge burden. And it means one can often start clinical trials months (many months) or years before having enough preclinical data to obtain FDA approval for a Phase I trial under the auspices of he FDA.

Butt, that said, I personally have never had a significant complain about the FDA. Many folks complain that is too slow - butt I personally think that the FDA, which is much more cautious in general than ex-US drug regulators and errs on the side of patient safety and requiring a lott of data and evidence, is IMO about right in its level of review and approval. Too strict for most, butt OTH it weds ~OUTT a lott of trials that really aren't sufficiently likely to succeed and will just waste a lot of patients' time and opportunity to try other trialed drugs or alternative existing drugs or devices.

And one more thing as a general comment. Many people who have no knowledge or personal involvement in the drug approval and drug safety monitoring system harbor a false belief (mostly, I'm sure there are exceptions - and frankly AMAG, a situation I am well aware of, is one of them IMO) that evil drug companies CONspire to fabricate, conceal, or misrepresent data to get drugs approved. I can assure you from personal experiences that such a claim is (with some exceptions) very, very much untrue. The stupidest, worst thing a company or its agents can do with regard to the FDA is to fudge data, misrepresent something, fail to report adverse events, or just lie to the Agency. The folks at the FDA do and will hold a grudge against anyone and any company (or CRO) that does this. Your future interactions with h Agency will go to shit and your timelines will be drawn waaaaay ~OUTT. You may be personally debarred by the FDA and essentially unemployable in the pharma industry. Every senior person in a company who applies for an FDA manufacturing license gets fingerprinted and an FBI background Czech is done on them as well as by the FDA itself, and every such person has a 'record' with the FDA thereafter - assuming they PASS the review.

The biggest, dumbest thing one can do is to try and fool the Agency or do something one ought nott do - like unapproved marketing materials and making claims about unlicensed drugs before they are approved after SPECIFICALLY being warned by the Agency. That's a great way to find oneself ~OUTT of the pharma industry and looking for an entirely new career - selling used cars or driving for Uber.

The folks on both sides (generally), the FDA personnel and the company's medical staff, CRO(s), CMO(s) (which creates a DMA - Drug Master File), and manufacturing management (and lawyers who specialize in FDA practice - nott me) are genuinely first and always CONcerned with patient health and safety. The system requires this. The people involved also have professional ethics requirements, legal concerns, and their reputation the line every time and in a bigly way. The CEO may have a different view, butt the company professional medical, manufacturing, and legal folks, whether in-house or outhouse professionals, in my experiences, always always always put patient safety first. If they don't, they will nott last long in this biz. Nobody will ever want to have that person in their company - they are DONE. Either formally or informally by shunning. One of the sources of friction in smaller pharma companies SOMEtimes happens when a CEO or COO wants one f these folks in Medical Affairs or manufacturing to fudge an issue; in my experience, that is like yelling at the wall - the Med Affairs and manufacturing folks ain't gonna fudge stuff just because the CEO tries to pressure them to do so. As long as your reputation is good there is always a yobb for you elsewhere - it's better to risk the CEO firing you - or you just quit - than to lose your ability to work in this biz by fudging data or an issue - or just nott being timely in reporting it. Only fools do such things, and there are (generally) no fools who make it to upper-level Med Affairs or Manufacturing yobbs.

The real prollem often is the marketing and sales parts of the biz. Butt they only really interact with the FDA as relates to promotional materials and how they can use an indication claim. I will nott defend marketing and sales folks in this biz, because many of them do nott deserve being defended - and they are IMO too often unprofessional and unethical. And marketing folks often try to pressure the Med Affair or manufacturing folks and they too, ike the CEO, will generally nott be able to sway Med Affairs and manufacturing folks to do anything that will damage their reputation with the Agency or with others in the biz. People with good contacts and good reputation with he Agency are in HIGH demand, as they can often facilitate matters with the Agency based in part on knowing the respective people in the Agency and having established a record for their personal (or lesser so for a corporation or other entity) for honesty, ethical behaviour, timely disclosure of adverse data or events, and respect for their thoroughness and medical/scientific knowledge. THAT is their stock-in-trade. That is why such people are in HIGH demand and often gett compensated very highly as is required to recruit and retain such people - they are sometimes paid more than every other member in the C-suite except the CFO. And I have seen at least one case where, through the use of performance-based stock options grants and bonuses, a Med Affairs person netted MORE than the CEO in at least one year.

Nobody with a brain throws that reputation and its ongoing value in the toilet for a CEO or company. Nor risk prison time either.

In the pharma biz (in the USA anyway), patient safety is always paramount among the medical, scientific, and manudfacturing professionals. It prolly doesn't SEEM like that because of the various exceptions to this rule and because some marketing/sales goons and/or the CEO are nott to the same level of ethics and professionalism and thus there are many examples where things have gone wronGGG or been CONcealed or delayed due to those folks.

But the Agency (FDA) and the private sector professionals who interact directly with the Agency are seriously most concerned with safety first and efficacy second. Of course even highly knowledgeable professionals can be wronGGG and later in post-marketing surveillance (which is required!) and post-approval (Phase IV) clinical trials new data can be found that indicate prollems with an approved drug. This happens a lott because this is all experimental. A prollem that didn't occur in the hundreds or thousands of patients in pre-approval clinical trials can show up when the drug is approved and marketed and used in hundreds of thousands or millions or tens of millions of patients. This is common - sometimes a minor side effect and other times it kills a tiny percentage of the patients (in which case the drug is often pulled from the market unless the indication - like for desperate patients like cancer or orphan diseases - is so important that the risk/reward analysis indicates it's better to risk a small number of patient deaths compared to all the benefit the drug or device provides to others.

I will nott defend most gummint agencies, butt the FDA is one that I will defend. It does good work and is IMO better than any similar pharma or device regulatory authority in ANY other country, and that includes the EMA.

Oh, and BTW, the reason almost all pennyscam bipharmas are hopeless is, in part, because generally quality Med Affairs and manufacturing folks won't go near them and thus those penny companies will have tough sailing with he FDA, even IF the rare lottery ticket his and hte drug or device works. Without the capital and the regulatory folks, it will take a long time and possibly even forever to get that drug approved. And any drug candidate or device that has any real potential value is locked up in a deal with Big Pharma long before pivotal clinical trials - in part just to fund them - and in part to take advantage of the Big Pharma partner's Med Affairs, Regulatory, and Manufacturing people and expertise, reputation, and FDA contacts.

Ergo, most all pennystock biopharmas are junk.





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