FDA to Emphasize Safety in Approving Drug Names

The way in which the FDA approves proposed drug names is changing as the agency increases its focus on drug safety through preventing medication errors.

The Division of Medication Error Prevention (DMEDP) is taking the lead in regulatory actions related to proprietary name review and medication error prevention, Susan Proulx, president of Med-ERRS, said at an FDAnews audioconference last week.

Previously, DMEDP checked proposed drug names to see if they were similar enough to existing drug names to potentially cause medication errors. It then issued a recommendation to the relevant drug-reviewing division, which could overrule it.

Under a memorandum of agreement signed this month between the FDA’s Office of New Drugs and Office of Surveillance and Epidemiology (OSE), “there will be more transparency, and DMEDP will have more say,” Proulx said.

DMEDP may get the final say on whether a proposed drug name can be approved rather than the reviewing division, she added. The goal is to improve drug safety by decreasing the risk of medication errors caused by name confusion.

SEC Slaps CPA Firms for Not Registering

The Securities and Exchange Commission took action against several small accounting firms and their principals, saying they audited public companies without having registered with the Public Company Accounting Oversight Board (PCAOB).

Each of the firms and individuals consented to the issuance of the SEC orders without admitting to or denying any of the findings.

FDA flubs off-label enforcement

The FDA takes too long to warn a pharmaceutical company about off-label promotion, according to a Government Accountability Office (GAO)

According to the GAO, the FDA:

• Takes an average of seven months to warn a company about possible violations
• Is unable to review all submissions because of the volume of materials it receives
• Prioritizes reviews to examine those with the greatest potential impact on human health
• Relies on staff to sort though large volumes of material and prioritize them for review
• Is hampered by the lack of a system that consistently tracks the receipt and review of submitted materials

Between 2003 and 2007, the FDA issued 42 letters requesting companies stop marketing products for off-label uses, but did not refer any of the violations to the Department of Justice (DOJ) for enforcement actions. During the same time, the DOJ settled 11 civil and criminal cases that involved off-label marketing to some extent.

Senator Charles Grassley (R-IA) requested the review.

Source: ePharmaceuticals

PCAOB Approves Succession Rule

The change will make it easier for accounting firms to continue their work after a merger.

The Public Company Accounting Oversight Board on Tuesday approved a new rule that will allow accounting firms to keep their registered status after a merger or change of name.

The rule—and the accompanying form—spells out the circumstances where a firm can keep its registration status even if it becomes a new “legal entity.” First proposed in May 2006, the new rule is intended to protect auditors from having to stop their work because of a gap in their registration status.

“Today’s action will allow for registered firms—in appropriate and well defined circumstances—to provide audit services without a break in their PCAOB registration status when there has been some change in their legal form,” PCAOB Chairman Mark Olson said. “The rules would provide flexibility that is important given the serious implications of a firm operating without registration.”

The circumstances include any changes in a firm’s legal organization or the jurisdiction in which it’s organized. A registered firm can also continue operating if it acquires or combines with an unregistered firm to form a new company.

“An issuer’s compliance with federal law and regulations depends upon its auditor being registered,according to the proposal, which added that “disruption of a firm’s registration should not be taken lightly.”

The PCAOB unanimously approved the new rule, which will be submitted to the Securities and Exchange Commission for final approval.

Source: CFO.com

The Top 10 Enterprise Risk-Management Myths

To address Sarbanes-Oxley compliance, many companies put in place technology platforms that now support a variety of risk and compliance initiatives. Sarbanes-Oxley solutions were generally purchased with the tacit approval of IT, but few IT organizations standardized on a strategy for managing risk and compliance data.

A lot of companies have moved to augment enterprise risk management platforms with dedicated governance, risk and compliance (GRC) solutions. That trend isn’t going to disappear anytime soon, but some companies will likely come away disappointed with the results. It’s fair to say that automation can seem like anything but in a lot of cases. Newsfactor.com offers a list of 10 ERM-GRC myths.

Few companies can grow without taking risks. But poor risk management leads to surprises in business operations that can impact shareholder confidence, regulatory oversight and the bottom line. An unprecedented wave of regulatory oversight in recent years has convinced many organizations how inadequate their enterprise risk management (ERM) policies and procedures really are.

1. Myth Number 10: IT Risk Management = Information Security
2. Myth Number 9: CIOs Embraced Enterprise GRC
3. Myth Number 8: A Rigid, Standardized Approach Is Best
4. Myth Number 7: You Can Manage Risk Only from the Center
5. Myth Number 6: You Can Manage Risk and Compliance with Spreadsheets
6. Myth Number 5: Traditional Audit Planning Is Good Enough
7. Myth Number 4: Enterprise Risk Management Is Dead!
8. Myth Number 3: It Just Takes Common Sense
9. Myth Number 2: TJX — It Can’t Happen Here
10. The Number One Myth about ERM: You Can’t Plan for the Unknown

Sketch of Gujarat blast suspect released

It is the first clear lead in the Gujarat terror strike. The police has a sketch of a suspect to work on. He was allegedly seen putting explosives in one of the cars found in Surat on Sunday. Luckily that bomb was defused.

Minutes after yet another bomb was detected in the textile town and defused before it could cause damage.

This is the third narrow escape for people in Surat in the last twenty-four hours. The device is a cocktail of ammonium nitrate, shrapnels, timer-device, at a place where people congregate.

Surat on alert; more bombs recovered

Just two days after four bombs were found in Surat, six more live bombs were found in the city, four of which were defused by the Bomb Disposal Squad. Efforts are on to defuse the fifth and sixth bombs.

Earlier, the first bomb was found near the Ladeshwar Police Chowky in the Varaccha area of the city. Another live bomb was recovered from a market in Santosh Nagar, and was confirmed by Assistant Commissioner of Police, Surat. The other explosives were reportedly recovered from the Mini Diamond market in Varaccha area of the city.

Following initial reports of the same, Surat police officials rushed to the area. The bombs were reportedly detonators, which could have gone off causing minor damage to the surroundings.

The bombs recovered by the Bomb Disposal squad bare an uncanny resemblance with each other and the ones that were found on Sunday (July 27). The explosives are reportedly wrapped in a newspaper which looks to be from the city of Vadodara.

Police officials suspect that more explosive-like substances have been planted in different parts the city. Following the alerts, the police cordoned off the area and restricted the traffic. Pedestrians were asked to keep off the area for security reasons.

RS Brar, Commissioner of Surat Police said, “We have cordoned off the area. We have appealed to the public to inform us if they find any objects of suspicion. We will take immediate action and are doing our best to ensure safety in the city.”

Meanwhile, there were reports that the OPD at the Ahmedabad’s Civil Hospital had been evacuated after authorities reportedly received a call informing of a possible bomb. However, the police confirmed that it was a hoax call.

High alert had been sounded in Surat after four live bombs were defused on the outskirts of the city on Sunday (July 27)

FDA issues guidance on pre-market approval applications

Four different types of action by the FDA can affect the agency’s review time for pre-market approval applications (PMA).

All four actions stop the review clock, or the period of time allowed for FDA review. In recently updated guidance, FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals, the FDA explained what the actions are and what is needed to resolve problems and restart the review. The actions include:

• Approvable orders, which require the applicant to resolve deficiencies in a PMA.
• Major deficiency letters, which require the applicant to supply significant information that is missing from the application.
• Not approvable letters, for items the FDA believes cannot be approved, which keep the application on hold while the applicant is given the opportunity to respond. The agency generally issues these only after sending a major deficiency letter and giving the applicant a chance to respond.
• Denial letters, which the agency issues when the review is complete.

The guidance also discusses the review cycle and performance goals the FDA has for processing both expedited and non-expedited PMAs and supplements. Finally, the guidance addresses the various actions applicants can take after submitting an application, including:

• Making unsolicited major amendments that introduce substantial new data
• Making solicited major amendments in response to an FDA request in a deficiency letter or not approvable letter
• Clarifying already submitted data with minor amendments
• Withdrawing the application

Click here and listen to webinar

FDA Rule and Companion Guidance Make Early Stage Clinical Drug Development Safe and Efficient

The U.S. Food and Drug Administration today issued a final regulation that makes early phase 1 clinical drug development safe and efficient by enabling a phased approach to complying with current good manufacturing practice (CGMP) statutes and FDA investigational requirements.

To facilitate this new approach, the regulation exempts most phase 1 investigational drugs from the requirements in 21 CFR part 211 — FDA will continue to exercise oversight of the manufacture of these drugs under FDA’s general statutory CGMP authority and through review of investigational new drug (IND) applications.

A companion guidance recommends an approach for complying with CGMP statutory requirements such as standards for the manufacturing facility and equipment, the control of components, as well as testing, stability, packaging, labeling, distribution, and recordkeeping.

“With this action, we are tailoring the CGMP requirements to make them appropriate to the earliest stages of drug development. This approach will ensure that these investigational products can be developed as efficiently as possible with the highest level of patient protection,” said U.S. Health and Human Services Deputy Secretary Tevi Troy.

When FDA originally issued CGMP regulations for drug and biological products (21 CFR parts 210 and 211), the agency stated that the regulations applied to all types of pharmaceutical production, but explained in the preamble to the regulations that FDA was considering proposing regulations more appropriate for the manufacture of drugs used in investigational clinical trials. The reason for this is that certain requirements in part 211 are directed at the commercial manufacture of products — such as repackaging and relabeling of drug products, rotation of stock, and maintaining separate facilities for manufacturing and packaging.  These types of requirements may be inappropriate to the manufacture of investigational drugs used in phase 1 clinical trials, many of which are carried out in small-scale, academic environments, typically involving fewer than 80 subjects.

“The new rule and guidance are intended to assure that manufacturers meet high standards for the safety of phase 1 drugs and biologics while removing unnecessary barriers that can slow the development of these potentially life-saving products,” said Rachel Behrman, M.D., associate commissioner for clinical programs and director of FDA’s Office of Critical Path Programs.

The guidance, CGMP for Phase 1 Investigational Drugs, describes an approach manufacturers can use to implement manufacturing controls that are appropriate for the phase 1 clinical trial stage of development. The approach described in this guidance reflects the fact that some manufacturing controls and the extent of manufacturing controls needed to achieve appropriate product quality differ among the various phases of clinical trials.

Manufacturers will continue to submit detailed information about relevant aspects of the manufacturing process as part of the IND application. The FDA may inspect the manufacturing operation, suspend a clinical trial by placing it on “clinical hold,” or terminate the IND if there is evidence of inadequate quality control procedures that would compromise the safety of an investigational product.

To find the Guidance for Industry, CGMP for Phase 1, Investigational Drugs, visit: http://www.fda.gov/cder/guidance/GMP%20Phase1IND61608.pdf

To find Current Good Manufacturing Practice and Investigational New Drugs Intended for Use in Clinical Trials/Final rule:  http://www.fda.gov/OHRMS/DOCKETS/98fr/oc07114.pdf

First arrest in Ahmedabad blasts case

An activist of the banned militant outfit — Ahle Hadeez — was today (July 27) arrested in connection with the serial blasts in Ahmedabad, which was on the edge with a live bomb in the city being defused and another three found in Surat city as the death toll rose to 49. The arrested activist, identified as Abdul Halim and wanted in connection with 2002 post-Godhra riots, was picked up by the police from the communally sensitive Dani Limda area in the walled city. Meanwhile, in New Delhi, Home Minister Shivraj Patil chaired a high-level meeting to review the situation in the country and assured all possible help to the Gujarat government.